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:

• Supports the clinical team in the overall management of studies, including planning, execution and closeout of one or more global clinical trials in accordance with clinical development plans/strategy and timelines
• Assist with the evaluation, selection, and oversight of CROs, external vendors and consultants to ensure successful clinical trial implementation and execution
• Contribute to the writing and review 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 is in accordance with GCP regulatory requirements and 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
• Assist with planning and conduct of investigators’ meetings
• Assist with monitoring 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 progress of studies/protocol compliance
• Participate in the preparation and review of SOPs
• Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes
• Perform any other business need identified by their direct line Manager.

 REQUIREMENTS:

• BA/BS required
• 7+ years of applicable clinical trial experience (5 years of vendor and CRO management) required including experience with phase III oncology studies.
• 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
• 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.