Global Clinical Project Manager - Sponsor Dedicated
- Accountable to deliver Trial(s) on time, within budget, and with highest achievable quality.
- Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
- Lead the evaluation and selection of investigative sites; responsible for feasibility.
- Select, coordinate and monitor activities of vendors Review of monitoring reports and conduct co- monitoring visits, as needed.
- Develop and manage trial(s) timelines, budget and priorities.
- Participate in data review and discrepancy resolution.
- Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
- Generate reports to update management on conduct of trial.
- Ensure appropriate clinical trial supply plans are implemented and managed.
- Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
- Participate in monitoring study safety.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
- Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
- Assist with CRA and third party vendor training on protocols and practices.
- Lead the multi-disciplinary trials teams; include the study team meetings.
- Function as the primary contact for trial(s) between Drug Development and other departments.
- Assume responsibility to participate as a member of working groups and perform special projects, as assigned.
- Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
- BS/BA degree or a relevant degree with strong emphasis on science.
- Minimum of 4 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
- Minimum of 3 years leading Global trials
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
- Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
- Demonstrate leadership and problem solving skills.
- Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
- Used to work in a multidisciplinary setting, strong cooperative team player, ability to be flexible and adapt to a changing environment.
- Good planning, prioritization, problem solving and organizational skills; strong customer-orientation, used to work independently.
- Strong communication skills, used to communicate with a broad range of stakeholders and to build strong positive relationships.
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