Senior Clinical Trial Manager

POSITION OVERVIEW:

Disc Medicine is hiring a new Sr. Clinical Trial Manager due 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 and lead the start-up and execution of large, global clinical trials. The ideal candidate thrives in a fast-paced, small-company environment where daily activities can fluctuate, requiring prioritization, flexibility and the ability to navigate uncertainty.

Excellent global study management and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment and with both in office and remote team members. The Sr. CTM is responsible for the management and oversight of CRO and vendors, as well as creating and managing study timelines, budgets and study management plans in a fully outsourced model. Reporting to the Associate Director of Clinical Operations, this position offers the chance to join a team of passionate colleagues with the opportunity for career growth.

RESPONSIBILITIES:

Clinical Trial Management & Execution – 50%

Covers end-to-end study support from planning through closeout:

• Support overall management of global clinical trials (planning, execution, closeout)
• Monitor study progress, budgets, and timelines
• Assist with planning and conduct of investigator meetings
• Perform periodic visits to sites/CROs to assess study progress and protocol compliance
• Review monitoring visit reports and ensure timely resolution of action items
• Liaise with clinical sites and Investigators to maintain effective Sponsor-site relationships

Vendor Oversight, Quality & Risk Management – 25%

Ensures compliant, high-quality trial delivery:

• Assist in evaluation, selection, and oversight of CROs, vendors, and consultants
• Review and approve vendor-generated operational plans
• Ensure audit readiness of trial documentation (including TMF)
• Ensure compliance with GCP and regulatory requirements
• Proactively identify, manage, and mitigate study risks

Clinical Documentation & Operational Support – 25%

Supports regulatory documentation and business operations:

• Participate in SOP preparation and review
• Contribute to drafting and reviewing clinical documents (protocols, ICFs, IBs, reports, ASRs/DSURs, status updates)
• Support meeting coordination, agendas, minutes, and metric tracking
• Perform additional responsibilities as assigned by the line manage

 REQUIREMENTS:

• BA/BS required
• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously
• 7+ years of applicable clinical trial experience (5 years of vendor and CRO management) required
• Thorough knowledge of FDA, EMA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Must be willing to travel both domestic and internationally
• 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
• Candidate should be a self-driven individual with skills in organization, building working relationships and communication.
• Strong business acumen: including in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., data management, biostatistics, regulatory, pharmacovigilance, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.