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.
Position Description
Serve as the site facing role for clinical operations at sites within a region.
Expedites the pre-study and study initiation processes including conduct of Pre-Study Evaluation and Site Initiation Visits in collaboration with Site Managers and/or Protocol Managers, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.
Identify, evaluate and recommend potential investigators/sites on an on-going basis within assigned region.
Conducts targeted risk based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable BMS SOPS, subject protection and ICH and/or FDA GCP Guidelines and other local regulations. Manage multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and or/geographic territory. Significant travel outside of region is rare.
Ensures timely entry and quality of data submitted from study sites.
Supervises overall activities of site personnel’s study conduct and motivates and influences site personnel to meet study and timeline objectives.
Anticipates and proactively resolves study site issues using critical thinking skills. This includes the ability to conduct root cause analysis, implementing corrective actions, ensuring appropriate preventative actions are developed, implemented and being followed and finally the ability to demonstrate via verbal and written methods the process or “story” of the issue.
Ensures documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary.
Facilitates, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites.
Provides monitoring assistance to site monitor colleagues within and outside of region to ensure timely execution of deliverables (as needed).
As a Clinical Site Monitor, serves as the example of professionalism, collaboration and efficient execution of deliverables.
Proactively communicates and escalates, with all internal and external stakeholders, any significant issues identified at study sites while developing corresponding mitigation strategies and solutions.
Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.
Initiates, develops and grows professional and collaborative relationships with internal/external study personnel and necessary institution stakeholders.
Effectively prioritizes time in order to meet goals and deadlines.
Passionately utilizes critical thinking skills and embraces change (effective change agent) for systems, processes and tools.
Observe site/CRO relationships and communicate / connect with internal stakeholders to meet BMS study goals and/or milestones. Be a BMS/site level advocate to ensure impact on issues do not include significant concerns without necessarily resolving the issue directly.
Demonstrates ability to adapt complex verbal and written information into concise messages.
Builds, cultivates, and maintains customer relationships and identifies synergies between customer needs and the company’s interests
Proactively seeks opportunities for development in the organization
Position Qualifications/Requirements
3-5 years of clinical research or pharmaceutical developmental experience, of which at least 2 year must be clinical research monitoring.
At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution.
Thorough knowledge of ICH/FDA guidelines and Knowledge of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US is also helpful.
Working knowledge of Remote Data Capture, EMR and computer based systems.
Possesses knowledge of industry trends (Risk Based Monitoring, Remote Monitoring, Remote Source Data Verification/Review, etc.)
Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills.
Exhibits a high level of flexibility for changing priorities and processes.
Exhibits strong fiscal responsibility by independently managing travel and functional expenses.
Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.
Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.
Ability to successfully manage an assigned workload by using critical thinking skills, prioritizing actionable items and making appropriate decisions as well as action plans.
Has demonstrated ability to work independently with oversight by line manager
Effective communication skills (emotional intelligence, verbal cues, non-verbal cues, adapting for audience, and listening to create openness and trust).
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.
