Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Director, Global Regulatory Sciences Liaison & Strategy - Europe Oncology

Expected Areas of Competence:

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Excited to grow your career?

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

We are now looking for the Associate Director, Global Quality Clinical Trials and Safety Strategy & Operations

Who will be the strategic and operational partner to the Head of Global Quality Clinical Trials and Safety and specifically support the management of budget, resources, monitor progress of improvement initiatives, communication strategy and be the co-lead of the Serious Breach assessment Committee and be the approver of deviations for the procedural documents.

Key Responsibilities and Major Duties:

•Assist functional leaders in delivering transformative operating model enhancements that improve pipeline delivery and enhance Global Quality business performance

•Assisting functional leaders in the design and implementation of short- and long-term Global Quality business strategies

•Manage resourcing model for Global Quality Clinical Trials and Safety

•Manages budget to ensure proper and efficient use of allocated budget

•Support communication flow, including creating materials to share trends in audit and inspection findings

•Assure that initiatives within Global Quality Clinical Trials and Safety  are kept on track and managed effectively through use of formal Charter review and approval process, and oversight involvement in key global initiatives

•Drive & coordinate departmental planning and associated tasks.

•Work with Global Quality Clinical Trials and Safety Head to implement strategies to develop people and culture in alignment with GQ and company strategy

•Collaborate with major customers across R&D including senior managers as well as Global Quality supporting functions

Experience Desired:

•Bachelor or Master Degree within life sciences or equivalent

•Minimum 8-10 years of relevant experience in clinical research in pharmaceutical or healthcare related industry required

•Proven project management experience, with a strong background in the operational aspects of clinical research studies.

•Experience in resource planning, budgeting techniques and process improvement preferred.

•An in-depth understanding of clinical research processes and regulations.

•Ability to work independently in a fast moving and increasingly complex environment with limited direction is required

•Position requires very strong written and oral communication skills, as well as strong interpersonal and organizational skills.

•Individual must possess the ability to build alignment and drive performance across matrix teams through personal influence.

•Demonstrates the ability to lead and motivate team members according to strategic goals.

•Good verbal and written communication skills (both in English and local language)

•Microsoft Suite

•Clinical Trial Management Systems

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Database Developer, Clinical Data Acquisition & Standards is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director or the Senior Database Developer, Clinical Data Acquisition & Standards within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO).   

This is a full-time, office-based position located in Central New Jersey, USA or Braine-l’Allaud.

Responsibilities Include

Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.

Managing own work assignments to ensure timely delivery of study databases.

Working with Data Management to develop appropriate timelines for development and deployment of study databases.

Identifying and resolving issues which may negatively impact delivery of study databases.  Escalating issues to leadership as needed.

Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.

Contributing to the development and application of smart systems and optimal approaches to support the collection of data.

Actively participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.

Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services on behalf of BMS.

Developing productive working relationships with key stakeholders throughout GDMCM and GCO.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.

Experience and Expertise Required

Bachelor’s degree required with an advanced degree preferred.

At least 4 years of relevant industry experience.

At least 3 years of database development experience in Rave. 

Project management certification (e.g. PMP) is desirable.

Global clinical trial knowledge.  Immuno-Oncology therapeutic experience is highly desirable.

Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.

Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

Strong knowledge of GCP/ICH guidelines.

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together.  Driven to make a difference, from innovative research to hands-on community support.  Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The Senior Database Developer, Clinical Data Acquisition & Standards is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director – Database Development, Clinical Data Acquisition & Standards within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO). 

This is a full-time, office-based position located in Central New Jersey, USA or Braine-l’Allaud.

Responsibilities include:

• Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.
• Managing work assignments to ensure timely delivery of study databases.
• Working with Data Management to develop appropriate timelines for development and deployment of study databases.
• Identifying and resolving issues which may negatively impact delivery of study databases.  Escalating issues to leadership as needed.
• Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.
• Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
• Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
• Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services on behalf of BMS.
• Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.
• Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.
• Some Senior Managers may also be responsible for managing Functional Service Providers - Reviewing deliverables and timelines, providing ongoing feedback and performance review, empowering and holding staff to high quality performance and delivery. 

Experience and expertise required: 

• Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.
• At least 5 years of database development experience in Rave. 
• Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.
• Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.
• Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
• Strong knowledge of GCP/ICH guidelines.
• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
• An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
• Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

This is a full-time, office-based position located in Central New Jersey, USA or Braine-l’Allaud. 

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Senior Database Developer, Clinical Data Acquisition & Standards is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director – Database Development, Clinical Data Acquisition & Standards within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO). 

This is a full-time, office-based position located in Central New Jersey, USA or Braine-l’Allaud.

Responsibilities

Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.

Managing work assignments to ensure timely delivery of study databases.

Working with Data Management to develop appropriate timelines for development and deployment of study databases.

Identifying and resolving issues which may negatively impact delivery of study databases.  Escalating issues to leadership as needed.

Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.

Contributing to the development and application of smart systems and optimal approaches to support the collection of data.

Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.

Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services on behalf of BMS.

Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.

Some Senior Managers may also be responsible for managing Functional Service Providers - Reviewing deliverables and timelines, providing ongoing feedback and performance review, empowering and holding staff to high quality performance and delivery. 

Experience and Expertise Required 

Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

At least 5 years of database development experience in Rave. 

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.

Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

Strong knowledge of GCP/ICH guidelines.

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Senior Manager, Clinical Data Acquisition & Standards (Database Developer) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Clinical Data Acquisition & Standards (Database Development) within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO). 

This is a full-time, office-based position located in Central New Jersey, USA or Braine-l’Allaud.

Responsibilities

Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.

Managing work assignments to ensure timely delivery of study databases.

Working with Data Management to develop appropriate timelines for development and deployment of study databases.

Identifying and resolving issues which may negatively impact delivery of study databases.  Escalating issues to leadership as needed.

Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.

Contributing to the development and application of smart systems and optimal approaches to support the collection of data.

Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.

Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services on behalf of BMS.

Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.

Some Senior Managers may also be responsible for managing employees and/or Functional Service Providers - Reviewing deliverables and timelines, providing ongoing feedback and performance review, empowering and holding staff to high quality performance and delivery. 

Experience and Expertise Required

Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience. Project management certification (e.g. PMP) is desirable.

At least 5 years of database development experience in Rave. 

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.

Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

Strong knowledge of GCP/ICH guidelines.

Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Senior Manager, Clinical Data Acquisition & Standards (External Data Setup Manager) is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director, Clinical Data Acquisition & Standards (External Data Setup) within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Clinical Operations (GCO). 

This is a full-time, office-based position located in Central New Jersey, USA or Belgium.

Responsibilities

​Driving the data collection strategy for vendor generated test results, championing consistency across programs and therapeutic areas.

Serving as the subject matter expert for the setup of external vendors at the study level, managing the completion of study start up, amendment and post final changes.

Creating data transfer specifications, ensuring vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting.

Working with Clinical Data Management to develop appropriate content and timelines for development and deployment of study databases.

Identifying and resolving issues which may negatively impact study deliverables.  Escalating issues to leadership as needed.

Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.

Contributing to the development and application of smart systems and optimal approaches to support the collection of data.

Actively participating in continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.

Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing testing or data collection services on behalf of BMS.

Developing strong and productive working relationships with key stakeholders throughout GDMCM, GCO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Representing the Company in interactions with key external partners as part of any committee or industry group.

Experience and Expertise Required

Bachelor’s degree required with scientific or data integration disciplines preferred.

At least 5 years of relevant industry experience with Data Management experience preferred.

Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena.

Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

Strong knowledge of GCP/ICH guidelines.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Global Quality & Regulatory Compliance, Clinical Trials & Safety

(Senior Compliance Auditing Manager)

GQRC-CT&S is responsible for auditing all processed related to clinical research including specific medical affairs processes, and pharmacovigilance activities, to assess compliance with relevant regulations and applicable policies and procedures. This includes investigator site, internal systems (e.g. REMS), and external vendor audits. It is also responsible for management of regulatory agency inspections and for providing advice on regulatory requirements.

Purpose/Objective of the job:

To conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits.

To act as project-specific liaison between GQRC-CT&S and key stakeholders, including Global Development Operations and Global Regulatory & Safety Sciences personnel, monitoring the status of the project(s) to plan audits and assuring GQRC-CT&S leadership is informed.

Key Responsibilities and Major Duties/

• Perform GCP audits of investigator sites, vendors and internal systems.
• Act as lead auditor, develop the audit plan and determine priorities for the audit. Prioritize and focus on matters of significance.
• Collect information through effective interviewing, listening, observing and reviewing documents, records and data.
• Maintain an in-depth knowledge of governmental regulations, which impact the research and development of medicines, as well as the most relevant Bristol-Myers Squibb Company policies, directives, and procedures related to clinical research.
• Manage health authority inspections and/or review of findings, and make recommendations for corrective and preventative action.
• Provide advice and counsel concerning GCP-related regulatory requirements.
• As appropriate, represent BMS within trade and professional associations.

  List of minimum requirements:

• University Graduate, Life Sciences degree preferred.
• Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication.
• Good understanding of the drug development process.
• Excellent oral and written communication.
• Fluent in English and other languages, as applicable to assigned audit region.
• Sense of diplomacy and discretion.
• Maintains the confidentiality and security of information, data, documents and records.
• Demonstrates commitment to delivering high-quality work product.
• Knowledge of relevant BMS policies and procedures as well as governmental regulations impacting clinical research and development.
• Strong critical thinking to analyse complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions.
• Software: Microsoft Suite, ESF, Jreview, PRISM, Trackwise CAT, Sharepoint, other systems as assigned/applicable.
• Approximately 25% travel to perform audits and attend professional meetings and seminars.
• Approximately 5 days per month overnight absences required.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Protocol Manager is responsible to drive the successful and timely execution of global Phase I, II, III and IV clinical research protocols from study startup to final clinical study report within the established budget and timelines.

Serves as primary operational contact for the protocol. Coordinates the development of protocol level documents and plans, clinical supply oversight, vendor oversight, enrollment tracking, clinical data review and cleaning, coordination of audit responses, updating of various trial management systems, study close-out.

Demonstrates strong project management and organizational skills, monitors protocol progress and manages obstacles. Effectively leads a global team of individuals assigned to the protocol, demonstrating strong interpersonal and influencing skills, effective oral and written communication skills.

Knowledge Desired:

• Minimum education BA/BS. Scientific degree is highly preferred.
• Strong understanding of the pharmaceutical industry, and GCP, ICH and the regulatory guidelines as they apply to protocol management.
• At least 4 years of project management experience with at least 2 years in the pharmaceutical or healthcare industry.
• Demonstrates ability to drive clinical trial activities (experience in design, conduct and management of CTs: protocol and study report writing, monitoring, budgeting, regulatory obligations, AE reporting and managing CROs and external vendor
• Fluency in English is a must.

Experiences Desired:

• Excellent project and stakeholder management.
• Ability to multi-task and manage high performance demands.
• Experience in managing technology for information and communication tool (CTMS, IVRS, excel, Word, PowerPoint, etc.).
• Oncology experience is an asset.
• Strong communication skills.

BMS BioPharma Behaviors required

• Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
• Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
• Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
• Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.