Senior Clinical Trial Manager

The Sr 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, functions as the primary liaison for internal stakeholders and vendors leads multidisciplinary departments initiatives, and provides support for process changes to increase efficiency in study executions.

Essential Functions of the Job (Key responsibilities)

• 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.

• Manage 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.

• Develop 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, to improve the efficiency, effective and quality of the functioning of the Development Operations Department.

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

What you need to have:

• BS/BA degree or a relevant degree with strong emphasis on science.

• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.

• Able to manage complex and/or large trials.

• Must have non-malignant hematology clinical trial management experience.

• 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.

• To qualify, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status