50 Hampshire St
Job Category: Clinical: Clinical Operations and Development
Job Number: 2013
Reporting directly to the Head of Clinical Development, the Senior Clinical Trial Manager will lead the planning and manage the implementation of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model.
If you are looking for a highly visible, high impact role that comes with mentorship from, and exposure to, the highest levels of the organization, it is a great time to join this growing team. You will have the opportunity to not only learn and execute clinical operations in a fast paced, collaborative environment, but to help shape and define it!
This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans. This role will also manage Investigator Sponsored Trials. This position will help review/develop Clinical Operations processes and procedures for a growing department.
- Managing the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
- Leading the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
- Anticipating, recognizing and resolving issues; as necessary, managing escalation of study related issues with management and other R&D functions
- Contributing to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, trial reports and DSURs
- Reviewing and approving study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
- Ensuring audit-ready condition of clinical trial documentation including the trial master file
- Reviewing monitoring reports to ensure quality and resolution of site-related issues
- Serving as liaison with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Leading the planning and conduct of investigator’ s meetings
- Monitoring progress of clinical study activities and reporting on the progress of assigned clinical trials including budget and timelines
- Performing occasional and periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
- Participating in the preparation and review of SOPs
- Bachelor’ s degree is required. Scientific/health care field preferred, but not required.
- Minimum of 6 years in clinical development in pharmaceutical/biotech industry, at least 3 years of expertise in clinical trial management
- Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
- Experience in orphan indications and/or stem cell transplantation will be favorably considered
- Extensive experience managing complex protocols, CROs, budgets, and timelines
- Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
- Strong verbal and written communication skills including clinical authoring experience
- Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
- Proven track record of effective leadership with excellent organizational skills and ability to work independently
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
- Must be willing to travel both domestic and international