The Sr. Global Study Manager is responsible for all aspects of management of clinical studies. This individual participates in the development of clinical study strategy, and manages operational and logistical tasks of clinical studies to ensure their efficient execution within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, GCP/ICH guidelines etc. To achieve these goals, the Clinical Study Manager works with members of each project team, as well as subject matter experts (SMEs) in areas such as Product Development, Regulatory and Marketing. The Clinical Study Manager is the point of contact for all external resources, including Principal Investigators, clinical laboratories, external service providers, contract research organization, Institutional Review Boards, etc.
Essential Duties and Responsibilities:
- Participate in setting strategic direction and hands-on leading clinical trials and multicenter studies.
- Manage and/or coordinate all aspects of clinical research trials, including planning, study designs, site selection, contracts with study sites and Principal Investigators, IRB approvals, subject recruitment, site training, study execution and oversight/auditing, data collection, documentation, site close-out and generation of study reports.
- Ensure that study designs and outcomes support regulatory submissions.
- May co-author and/or work with KOLs and others to develop publications based on the results of the clinical studies and trials.
- Provide updates and status reports to senior management on a regular basis; report on performance against plan.
- Develop and manage the budgets for clinical studies. Ensure overall operation is within the approved budget and timeline.
- Develop and implement SOPs for clinical studies and related activities.
- Ensure compliance with all applicable regulatory standards related to global clinical studies and trials and interactions with physicians.
- Interface with departments within and outside. including Product Development, Manufacturing, Regulatory Affairs.
- Coordinate and/or manage internal staff and outside partners/service providers.
- Serve as the central point of contact between and among internal and external resources participating in clinical studies.
- B.S. or Master's degree in related field required
- 6-8years of experience in Oncology clinical trials, in pharma or biotech with evidence of and hands-on managerial experience running clinical trials managing teams.
- Experience with all aspects of management of clinical trials from inception to completion.
- Strong knowledge of FDA , ICH/GCP.
- Previous experience in preparing study protocols, IRB submissions, eCRFs and site contracts.
- Previous clinical trial site management experience (set-up, training, auditing, close-out).
- Knowledge of and experience in establishing clinical study designs.
- Basic understanding of eTMF
- Knowledge of Good Clinical Practice (CGP).
- Strong project planning, leadership, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
- Extraordinary researching skills and expertise in searching medical literature and databases for clinical and technical information.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Ability to forge cross-functional working relationships with internal teams and external project partners.
- Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
- Superior writing skills and ability to effectively communicate with technical and non-technical people.