Bristol-Myers Squibb Company

Senior Clinical Site Monitor (ref.#9923)

Location
Princeton, NJ, United States
Posted
Jul 20, 2019
Ref
R1516852
Required Education
Bachelors Degree
Position Type
Full time
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.

Employer: Bristol-Myers Squibb Company

Position: Senior Clinical Site Monitor (ref.#9923)

Location: Route 206 and Province Line Road, Princeton, NJ 08543

Duties

Use experience in pharmaceutical development; experience with advanced site monitoring/management in a complex small molecule and biologic trials in a wide array of diseases across the development spectrum; extensive knowledge of ICH/GCP guidelines and global health authority regulations; knowledge of Remote Data Capture, EMR and computer based systems; and project management skills to serve as the site facing role for clinical operations at sites within a region. Expedite 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. Identify, evaluate and recommend potential investigators/sites on an on-going basis within assigned region. Critically review and analyze site activities through 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. Ensure timely entry and quality of data submitted from study sites. Anticipate and proactively resolve study site issues. Ensure documented follow-up to all outstanding issues within monitoring management system ensuring appropriate issue escalation to line manager and project team members as necessary. Facilitate, as needed, internal regulatory compliance audits and Health Authority inspections for assigned sites. Provide monitoring assistance to site monitor colleagues within and outside of region to ensure timely execution of deliverables. Proactively communicate and escalate with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions. Prepare and submit monitoring and management reports in a timely, accurate, concise and objective manner. May work from home office 2-3 days per week. Position requires travel to perform site monitoring visits within the Southeast region of the US US 25-35% of time.

Requirements

Bachelor's degree (or foreign equivalent) in a Health related field plus 5 years of post-baccalaureate experience showing demonstrable ability in the skill set described above including 5 years of site monitoring experience.

**This position is eligible for our employee referral program.

Contact

Katherine Russaw Horton

Bristol-Myers Squibb

3551 Lawrenceville Road

Princeton, NJ 08540

resume.com@bms.com

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.