Clinical Trial Acceleration Manager
5 days ago
This role has task-level responsibility for document and CTA package creation supporting all BMS Clinical Trials across the enterprise. The ideal candidate will engage closely with clinical trial vendors across multiple service categories of clinical trial activities in R&D.
About the JobWe are seeking a highly organized and detail-oriented Clinical Trial Acceleration Manager to join our team. As a key member of our global trial team, you will be responsible for managing and executing centralized activities in support of global trials with an emphasis on clinical documentation.
You will interact with clinical study sites, Central IRB/IECs, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitor (CTMo), the study team, and other functional areas within BMS. Your primary focus will be on developing and maintaining collaborative working relationships with clinical investigative sites to ensure compliance with regulatory standards and ethical practices.
Main Responsibilities:- Initiate and manage global start-up documentation activities for clinical trials
- Generation, processing, tracking, and distribution of Confidential Disclosure Agreements (CDAs)
- Provide input into the creation of the feasibility questionnaire; distribution and tracking of the questionnaires; provide coordinated feedback to Global Trial Manager (GTM), CTM, Study Team, and BIA as applicable
- Submission of potential investigators to CTSS for debarment review and tracking of decisions
- Review of essential regulatory documentation and interaction with sites to resolve outstanding issues; including submission of final documents to the electronic Trial Master File (eTMF)
- Responsible for Site Activation for clinical trials as applicable per region; this includes the final review of applicable documents, final sign-off of the site activation checklist, and submission to Regulatory
- Update and review of various study-related clinical systems to determine and report status of clinical trial documents for insourced studies (i.e., CTMS, eTMF, etc. or corresponding vendor systems)
- Coordinate certified translation of study level documentation as requested (i.e., ICF, Protocol, IB)
To be successful in this role, you will need:
- A minimum of a BA or BS Degree in Legal, Life science, Business Administration, or equivalent experience
- Clinical development experience of 5 to 7 years of relevant industry experience (pharma, biotech, CRO, or similar fields) required
- Proven experience of working according to ICH/GCP and regulatory guidelines/directives, understanding of drug development process, and Pharma, Strong organizational, time-management, analytical, and decision-making skills
- Computer skills - MS office suite, Sharepoint, etc. CTMS (Veeva experience preferred, knowledge of portals, databases, and other Clinical Trial enabling technologies
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure
- Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts
The estimated salary for this role is $120,000 - $150,000 annually, depending on location and experience. We offer a comprehensive benefits package, including medical, dental, vision, 401(k) matching, and paid time off.
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