Clinical Site Monitor

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.

Responsibilities

Serve as the site facing role for clinical operations at sites withinthe 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.

Identifies, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.

Critically reviews and analyzes 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. This includes but is not limited to: Managed 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.

Proactively communicates, and escalates with all internal and external stakeholders any significant issues identified at study sites while developing corresponding mitigation strategies and solutions, including the following activities: root cause analysis, corrective, and preventative action plans.

Ensures timely entry and quality of data submitted from study sites.

Supervises overall activities of site personnel over whom there is no direct authority and motivates and influences site personnel to meet study and timeline objectives.

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.

Prepares and submits monitoring and management reports in a timely, accurate, concise and objective manner.

Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders.

Understands proper ownership of activities including the importance oftimely discussions, problem solving, andescalation as needed

Position qualifications/requirements

5+years of pharmaceutical development experience with 4-5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases across the development spectrum (phases I-IV). Oncology experience preferred.

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 understanding of global Health Authority (e.g., EMA, MHRA) regulations impacting activities in the US.

Thorough technical working knowledge of Electronic Data Capture, Electronic Medical Records and computer based systems.

Understanding 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 and adaptability for changing priorities and processes.

Employs strong fiscal management of departmental budget by independently managing travel and functional expenses.

Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time.

Demonstrates project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders.

Note:

This position will support the Northeast Region, may require overnight travelof approximately 20%and should be ideally located within one hour of the New Haven,CT area.