Senior Clinical Trial Manager
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
Disc Medicine is hiring a new Senior Clinical Trial Managerdue to the fast growth of the programs in the clinic. We are looking for someone to be an integral member of the Clinical Operations team to lead the planning, implementation, and management of clinical research studies.
The successful candidate will have excellent study management and oral/written communication skills with the ability to work in a collaborative, cross-functional team environment with onsite and remote team members. The Sr. CTM creates and manages study timelines, budgets, and study management plans in a fully outsourced model. Reporting to the Associate Director, Clinical Operations and Clinical Sciences, this position offers the chance to join a team of passionate colleagues with the opportunity for career growth.
- Manage the cross-functional study team to design, develop, execute, and deliver clinical studies in accordance with clinical development plans/strategy and timelines.
- Lead the evaluation, selection, and oversight of CROs, external vendors, and consultants to ensure successful clinical trial implementation and execution.
- Contribute to the writing and reviewing of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, and trial status updates.
- Review and approve study-related operational plans generated by CROs and vendors, and ensure the documentation follows GCP regulatory requirements and is consistent with the protocol for assigned studies.
- Ensure audit-ready condition of clinical trial documentation, including the trial master file.
- Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
- Ensures risks are proactively identified, managed, and mitigation strategies implemented.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
- Lead planning and conduct of investigators’ meetings.
- Monitor the progress of clinical study activities and report on the progress of assigned clinical trials, including budget and timelines.
- May perform periodic visits to sites and/or CROs to assess the progress of studies/protocol compliance.
- Manage Investigator Sponsored Trials.
- Participate in the preparation and review of SOPs.
- Perform any other business need identified by their direct line Manager.
- BA/BS required.
- A minimum of 5 years of applicable clinical trial management experience is required.
- Preference for experience in managing Phase 3 trials.
- Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally.
- Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred.
- Must be willing to travel both domestically and internationally.
- Candidates with experience in orphan indications will be favorably considered.
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization.
- Experience working on project teams is required.
- The candidate should be a self-driven individual with organizational skills, building working relationships, and communication skills.
Disc Medicine is an equal opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.
Please note that agency phone calls or submissions will not be accepted.
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