Clinical Trial Manager
5 - 7 years experience • Biotech/Pharma
Location : Bridgewater, NJ
Duration : 12+ months (with possible extension) contract on W2
This position encompasses two sets of responsibilities.
1) Responsible for providing highest level quality assurance of AR /AR Amendment/PADER/PMA documents and assistance in execution of the process for generating these regulatory documents. This role includes quality assessment of both, the regulatory documents and the process to ensure the following: 1) that all studies are appropriately classified for inclusion/exclusion, 2) that all reportable studies sponsored by sanofi are included in the report, 3) that comments in the spreadsheet are accurate, 4) that study synopses for completed clinical studies meet the established standards, and 5) validation of all documentation for the ARs and/or amendments, e.g., NDA (New Drug Application), PADER (Periodic Adverse Drug Experience Report), and PMA (Pre-Market Approval) for submission to the FDA. In addition, the incumbent will track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates. This role will provide back-up support in the generation of these regulatory documents, and the candidate will be fully knowledgeable of the process.
2)The Clinical Trial Manager will support the GBU ISS Operations team by managing investigator-sponsored study operations and ongoing quality improvements in the processing and review of ISSs. The CTM will liaise with field medical teams, medical units, legal, and other departments as needed to ensure investigator sponsored study requirements are met or exceeded. The CTM is responsible for driving the timely execution of contracts and financial payments, budgeting and financial forecasting, tracking of ISS study progression, management of the ISS database, and for maintaining ongoing metrics and reports on a regular basis.
Exceptional project management, including managing multiple complex projects from start to completion
Knowledge of the regulatory requirements for NDA ARs, including knowledge of pharmaceutical clinical trial process and AR documentation requirements.
Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Experience in managing budgets and forecasts, as relate to clinical trials
Demonstrated superb organizational, time management and communication skills (verbal and written)
Demonstrated experience working on multiple projects simultaneously with significant attention to detail
Strong interpersonal skills with the ability to interact with all levels of the organization
Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines
Strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment.
BachelorDegree in business or science area with 5+ years pharmaceutical/biotechnology industry experience in clinical research, clinical operations or medical affairs is required. Prior experience working with Investigator Sponsored Trials and/or regulatory reporting within the pharmaceutical industry is preferred.