Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary

The purpose of this role is to provide leadership to the Trial Master File (TMF) Study Leads staff in order to ensure TMF compliance and inspection readiness for active studies at all times. The Study Lead Line Head reports into the Global TMF Process Lead and will support that role in creating/achieving TMF Process optimization.

Responsibilities

Supervisory responsibility for TMF Study Leads, provides training, support, and coaching as required

Oversees activities across studies to ensure compliance with TMF requirements

In collaboration with the TMF Study Leads, supports BMS audit/inspection readiness activities and consults with all relevant functions within and outside GCO to ensure readiness

Support the Global TMF Process Lead in developing Work Instructions, templates, plans and work assignments. Attend/represent the Global TMF Process Lead at key meetings

Support the Global TMF Process Lead in developing & implementing various TMF Process Initiatives to achieve quality and compliance.

Provides leadership, infrastructure, and subject matter expertise to the TMF organization

Prioritizes book of work for the TMF Study Leads and assign resources based on study portfolio changes

Grows and develops internal staff to strengthen the organization

Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities

Assists and trains internal and CRO teams on TMF processes

Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance

Communicate as appropriate with relevant stakeholders

Along with Global TMF process Lead, leads and participates in continuous improvement initiatives related to clinical trial documentation and TMF compliance

Address gaps in TMF compliance as highlighted by Quality metrics and KPI

Degree Requirements

Minimum of a Bachelor degree in Science, Pharmacy, or related field

Experience Requirements

At least 5-7 years of experience in health sciences or related industry

Strong working knowledge of TMF, eTMF and clinical document management systems.

Strong organizational and technical ability. Demonstrated Excel, PowerPoint, and SharePoint skills.

Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.