Clinical Trial Manager

About the role

The Clinical Operations Lead supports the Clinical Trial Manager/operational team in execution of the trial(s). The position includes direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. The Lead maintains effective communication with project team through oral and written correspondence, status reports to ensure alignment with study timelines.

Responsibilities

• Aid in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information.
• Participate in the feasibility and evaluation of investigative sites; working closely with the Clinical Trial Logistics group.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
• Aid in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retention plan.
• Plan and organize meetings with team support (e.g. investigator/coordinator meetings, DMC, SMC, safety call, etc.).
• Aid in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments.
• Aid in data review and discrepancy resolution.
• Aid in coordinating efforts with internal Pharmacovigilance, and safety group.
• Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g. Monitoring, Sample management, IVRS, Laboratory, etc).
• Participate as a member of the multi-disciplinary trial(s) team.
• Develop relationships with investigational sites and institutions to enhance conduct of the trial.
• Act as preliminary liaison for study sites to convey trial information, answer questions and in accordance with the escalation pathway.
• Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effectiveness and quality of the functioning of the Development Operations Department.

Requirements

• BS/BA degree or a relevant degree with strong emphasis on science.
• Minimum of 5 years of clinical trial management experience in the biopharmaceutical industry or other relevant clinical research experience.
• Candidates 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 authority experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Prior experience in assisting the conduct and management of multinational clinical trials is preferred.