Bristol Myers Squibb Manager, TMF Study Lead in Princeton, New Jersey
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.
The centralized TMF organization is responsible for the completeness and accuracy of the Trial Master File for all BMS-sponsored studies. The group will deliver technical expertise in the Trial Master File (paper TMF & electronic TMF) management and will provide support for the book of work for all BMS-sponsored clinical trials throughout the lifecycle of the trial. The group will support inspection readiness goals in compliance with ICH/GCP Guidelines, regulatory requirements and BMS internal policies.
Key deliverables include monitoring and assessing the overall health of the TMF, ensuring quality, completeness and timeliness in the eTMF for all heritage Celgene and BMS-sponsored studies, working with the study teams and Clinical Trial Managers. Subject Matter Expert for TMF/eTMF, spans across all therapeutic areas and research phases, collaborates with cross-functional teams, TMF Contributors, TMF Content Owner, eTMF Business Operations and CRO/third party vendor during the close-out and archival cycle of the trials.
Monitor the adherence to ICH/GCP Guidelines, regulatory requirements and BMS policies as it relates to the completeness and accuracy of the TMF at the study level by ensuring the required documents reside in the TMF as per the Study-Specific Master Plan and Master List and are inspection ready at all times.
At study completion, ensure the TMF is ready to be archived.
Coordinate the long-term storage archival of original documents and maintain document integrity per retention policies.
Ensure all expected documents are complete and final in eTMF in collaboration with TMF Content Owner and study team (study team serve as SME for their respective departments/functions).
Work proactively and prospectively with TMF Content Owner and TMF Contributors at Study, Country and Site level to ensure timely reconciliation and archiving of all Essential Documents in the TMF.
Ensure controlled access to eTMF Archive and other TMF-related archive systems, as applicable.
Ensure systems owners take any necessary actions aimed to protect from unauthorized changes, as relevant to the specific TMF system.
Ensure the study documentation received by third party is complete, includes a documentation inventory list, and meet quality criteria before archiving documents.
For documents transferred from the CRO, ensure transfer to appropriate long-term archive location.
For any documents that have been maintained in hard copy, prepare and pack the documents for archival at the designated BMS archiving vendor facility.
Upon approval by TMF Archivist, transfer paper documents to archiving vendor per BMS procedures.
Upon approval by TMF Archivist retrieve and return hard copy documents to the off-site archive vendor per BMS procedures.
Periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per established review schedule.
Monitor and identify TMF trends and escalate concerns to management.
Generate, organize, and deliver on TMF performance metrics at the site, study, country and compound levels.
Manage complex export requests for Health Authorities and divestitures and independently solve technical issues
Leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams.
Assist in overall change management and build collaborative relationships with cross-functional team and third-party vendors.
Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection.
Exhibit good project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines.
Display good time management skills, the ability to produce deliverables efficiently, meet timelines, and prioritize workload to meet business goals.
Provide support to TMF implementation, internal audits and regulatory inspections.
Demonstrate ability to make decisions, deliver on commitments, share knowledge, acknowledge other’s achievements, and collaborate with peers in order to meet objectives or timelines in a rapidly changing environment.
Minimum of Bachelor’s degree in a scientific or related discipline
At least 5 years of TMF experience required, including experience in study start-up, maintenance and closeout, and performing quality and completeness reviews.
Relevant experience in clinical trials related roles (i.e. clinical operations and project management). Previous experience with independently managing projects and handling concurrent tasks in a fast pace environment and delivering results within tight timelines is desirable.
Extensive knowledge and application of ALCOA+ standards, Good Clinical Practice, Good Documentation Practices and International Council for Harmonization guidelines (E6(R2))
Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology
Must have knowledge of Core, Country and Site level essential documents
Must have ability to navigate eTMF system and show advance proficiency with Window Office tools
Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review
Very strong communication and interpersonal skills, verbal and written, is required
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1535269
Updated: 2021-06-12 02:29:58.377 UTC
Location: Princeton,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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