Senior Clinical Trial Manager

ICON

Remote

The Senior Clinical Trial Manager provides input to the overall operational trial(s) implementation, manages trial(s) timelines, budget, feasibility, country identification and sites selection, enhanced patient recruitment, and functions as the primary liaison for internal stakeholders and vendors.

Additional responsibilities include:

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, 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 acordance with scope of work.
Assist with CRA and third party vendor training on protocols and practices.

You must have:

BS/BA degree or a relevant degree with strong emphasis on science.
Experience working within a global capacity.
Minimum of four years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical 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).
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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