Senior Clinical Trial Manager
Company Overview
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.
Position Overview
Disc Medicine is hiring a Sr. Clinical Trial Manager to lead the start‑up and execution of large, global clinical trials. The role offers a hybrid work model with flexibility to work remotely or from the headquarters in Watertown, MA. Reporting to the Associate Director of Clinical Operations, the Sr. CTM will manage CRO and vendor relationships, create and manage study timelines, budgets, and study management plans in a fully outsourced model, and work within a fast‑paced, small‑company environment.
Responsibilities
- Support the clinical team in planning, execution, and closeout of one or more global clinical trials in accordance with development plans, strategy, and timelines.
- Evaluate, select, and oversee CROs, external vendors, and consultants to ensure successful trial implementation and execution.
- Contribute to writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, and status updates.
- Review and approve operational plans generated by CROs and vendors, ensuring compliance with GCP regulations and protocol requirements.
- Maintain audit‑ready condition of clinical trial documentation, including the trial master file.
- Review clinical monitoring visit reports and ensure timely closure of outstanding follow‑up items.
- Proactively identify, manage, and mitigate risks.
- Liaise with clinical site staff and investigators to maintain optimal sponsor‑site relationships.
- Assist with planning and conduct of investigators’ meetings.
- Monitor progress of clinical study activities and report on budget and timelines.
- Perform periodic site and/or CRO visits to assess study progress and protocol compliance.
- Participate in preparation and review of SOPs.
- Support meeting scheduling and distribution of agendas/minutes.
- Perform any other business needs identified by the direct line manager.
Requirements
- BA/BS required.
- 7+ years of applicable clinical trial experience, including at least 5 years of vendor and CRO management, with experience in phase III oncology studies.
- Advanced skills in Microsoft Office and working knowledge of electronic data systems.
- Self‑motivated, proactive, and able to prioritize and manage multiple projects simultaneously.
- Thorough knowledge of FDA, EMA, and ICH GCP guidelines for global clinical studies.
- Willingness to travel domestically and internationally.
- Experience in orphan indications is a plus.
- Strong interpersonal skills for interaction with investigators, vendors, and all organizational levels.
- Experience working on project teams.
- Strong business acumen with understanding of multidisciplinary functions such as data management, biostatistics, regulatory, pharmacovigilance, etc., and ability to integrate multiple perspectives.
Pay
Salary range: $151,000 — $185,000 USD. Actual pay rates are determined by qualifications, experience, education, credentials, subject‑matter expertise, and internal parity.
Benefits
Disc Medicine offers comprehensive benefits and competitive compensation packages, along with a flexible work environment.