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Clinical Trial Manager (RDN17-05)
The Clinical Trial Manager is responsible for the successful execution of clinical trials from the protocol concept through the clinical study report. Manages all aspects of the study ensuring completion of study deliverables, and typically works on studies with moderate to high complexity (in terms of design, location, phase, etc.). Ensures all clinical trials are executed in compliance with international GCP (Good Clinical Practice) guidelines/regulations and SOPs.
- Manages all clinical aspects of study including:
- Responsible for selection, qualification, and management of vendors to support clinical trial execution
- Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables
- Proactively identifies and resolves clinical project issues
- Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel;
- Plans, executes, and leads study-specific meetings (e.g., internal core team meetings, investigator meetings, Advisory Committee)
- Participates in site monitoring visits as appropriate
- Provides input for the design of the Informed Consent Form(s), CRFs, monitoring conventions, edit checks, etc.
- Reviews monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Uses operational and therapeutic expertise to optimize trial design and execution.
- Typically works with the Director to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
- Develops relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
Qualifications (Education, Experience, Knowledge and Skills)
- BS/BA in life sciences preferred
- A minimum of 5 years of direct experience in clinical trial execution
- Experience managing clinical trials both fully outsourced as well as managed directly
- Excellent communication (verbal and written), organizational and problem solving skills
- Prior experience developing and managing clinical trial budgets
- Demonstrated experience with Phase I Oncology studies preferred
- Experience managing external contract research relationships.
FORMA Therapeutics’ scientists are passionate about discovering and developing medicines that will make a difference in oncology, inflammation & immunity, and other serious diseases. The Company’s fully integrated R&D team drives discovery and early clinical development of therapeutics for qualified targets in the areas of epigenetics, protein homeostasis and metabolism. Leveraging a world class network of academic investigators, clinical experts and partners, FORMA combines deep biology insight, chemistry expertise and early clinical development capabilities, to create drug candidates providing profound patient benefit.
FORMA is headquartered in Watertown, MA near the epicenter of the Cambridge Life Sciences cluster, with additional chemistry operations in Branford, CT. Check us out at www.formatherapeutics.com or follow us on @FORMAInc
Please send resumes to email@example.com and reference job code # (RDN17-05) in the subject line.
No phone calls please. Resumes from third party vendors will not be accepted.