Associate Director - Global Quality Clinical Trials and Safety

Clinical Dev

icon-location-marker Princeton - NJ - US
Posted 71 days ago Full_time R1515391

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.

Purpose/Objective of the job

·        Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.

·        Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, including Global Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel, monitoring the status of the project(s) to plan audits and assuring GQ - CT&S leadership as informed.

·        Represent GQ-CT&S as an expert in specific GCP/PV related areas

 

Key Responsibilities and Major Duties

·        Within multiple areas of GCP/PV expertise, act as an expert resource;trainer for GQ-CT&S and as liaison with key stakeholders to provide input into related audit strategy and plans

·        Within areas of expertise, maintain awareness of trends and new developments internally and externally

·        Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internal systems and clinical study reports to assess regulatory compliance;

·        Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewing documents, records and data;

·        Prioritize and focus on matters of significance;

·        Confirm the sufficiency and appropriateness of audit evidence to support audit findings and conclusions;

·        Assess those factors that may affect the reliability of the audit findings and conclusions;

·        Prepare clearly-written, concise, accurate and evidence-based audit report;

·        Maintain audit database

·        Review and assess (or support the review) received corrective and preventive action plans according to specified timelines to ensure resolution of audit findings and prevent recurrence.

·        Maintain an in-depth knowledge of governmental regulations impacting clinical research and PV and development of medicines.

·        Provide advice and counsel concerning GCP regulatory requirements.

·        Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.

·        Regularly evaluate key PV and clinical research processes to determine compliance with regulatory requirements and established standard operating procedures.

·        May provide mentoring for new GQ-CT&S staff, as needed.

·        Support upper management on the on-boarding of new hires

·        Represent GQ-CT&S position during internal and external meetings

·        Lead project related teams or workstreams as assigned

·        Act as an advisor and back up to the Director

·        Coordinate health authority inspections as assigned and maintain inspection tools repository

 

 

Supervisory Responsibility

·        None

 

Key Stakeholders/Contacts

·        Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally;

·        Contact with appropriate technical, supervisory and management personnel internally and externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.

·        Regular collaboration with GQ-CT&S colleagues and with GCO and GRSB personnel

·        Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of health authority inspections either at clinical sites or at BMS facilities.

·        Miscellaneous contacts as assigned by GQ-CT&S management

 

 

List of minimum requirements

o      Degree/Certification/Licensure

o    Bachelor´s degree required - Life Sciences degree preferred

 

o      Experience/Responsibility and minimum # of years:

o    Demonstrated expertise and specific technical knowledge of the GCP and PV areas subject to audit, as evidenced by at Ieast 8 years in the pharmaceutical industry 

o    Minimum 5 years technical auditing and/or related experience; PV and GCP auditing preferred

 

o      Competencies/Knowledge/skills

o   Strong skill in risk based prioritization

o  Strong critical thinking to analyze complex situations and discern critical issues and non-compliant situations and to recommend appropriate corrective and preventive actions;

o   Excellent understanding of the drug development process and end to end quality process

o   Support GQ-CT&S management on identification of areas to increase department efficiency

o  Demonstrates computer literacy and is able to function independently within an environment that relied heavily on technology for information and communication

o    Excellent oral and written communication;

o    Fluent in English (and other languages, as applicable to assigned audit region);

o    Sense of diplomacy and discretion;

o    Maintains the confidentiality and security of information, data and records;

o    Demonstrates commitment to delivering high-quality work product;

o    Knowledge of governmental regulations impacting clinical research and drug development

o    Understand the appropriateness and consequences of using sampling techniques for auditing;

o    Ability to make ethical, scientifically sound recommendations, consistent with company policy/strategy and cost effective;

o    Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment;

o    Develops strong working relationships with key stakeholders;

o    Ability to manage competing priorities.

o    Ability to lead change process within functional group

o    Possesses detailed knowledge of areas of expertise and could teach or mentor others

o    Develops and applies new methods and ideas to enhance performance

 

BMS Behaviors and Working conditions:

o   BMS Biopharma Behaviors required: Passion, Accountability, Innovation, Speed

o   Travel Required (nature and frequency) approximately 25% travel to perform audits and attend professional meetings and seminars.

o   Overnight Absences Required (per typical month): Approximately 5 days per month

Software that must be used independently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, 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.