Senior Clinical Trial Manager

Sr CTM - Von Willebrand Disease

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 (Keyresponsibilities)

• Accountable to deliver Trial(s) on time, within budget, and with highest achievablequality.

• 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 regulatorydocuments.

• Manage the evaluation and selection of investigative sites; responsible forfeasibility.

• Select, coordinate and monitor activities ofvendors.

• Review of monitoring reports and conduct co-monitoring visits, asneeded.

• Develop and manage trial(s) timelines, budget andpriorities.

• Participate in data review and discrepancyresolution.

• Ensure set up and maintain all systems in order to plan and implement trial(s) and trackprogress.

• Generate reports to update management on conduct oftrial.

• Ensure appropriate clinical trial supply plans are implemented andmanaged.

• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies asrequired.

• Participate in monitoring studysafety.

• 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 andpractices.

• Lead the multi-disciplinary trials teams; include the study teammeetings.

• Function as the primary contact for trial(s) between Drug Development and otherdepartments.

• 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 OperationsDepartment.

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

What you need to have:

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

• Minimum of 7 years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of global clinical trials.

• Able to manage complex and/or largetrials.

• Must have non-malignant hematology clinical trial management experience, Von Willebrand disease.

• Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authorityexperience.

• Ability to effectively manage multiple priorities across several protocols and therapeutic areassimultaneously.

• Demonstrate leadership and problem-solvingskills.

• Experience in executing a wide range of clinical trial activities (from initiation to clinical studyreport).

• 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