Clinical Trial Manager/Senior Clinical Trial Manager
Disc Medicine is hiring a new Clinical Trial Manager/Senior Clinical Trial Manager due to the fast growth of the programs in the clinic. This position is located within Disc Medicine’s Watertown, MA office, although remote work is currently in effect and open for this role. We are looking for someone to be an integral member of the Clinical Operations team and lead the planning, implementation and management of early phase clinical research studies.
Excellent 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 CTM is responsible for creating and managing study timelines, budgets and study management plans in a fully outsourced model. Reporting to the Director, Clinical Operations, 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 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.
- Lead planning and conduct of investigators’ meetings.
- Monitor 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.
- 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.
- 2-5 years of applicable clinical trial management experience required.
- 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 domestic and international.
- 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.
ABOUT DISC MEDICINE:
The people at Disc Medicine are dedicated to the discovery and development of novel therapies to transform the lives of patients who suffer from hematologic diseases. Disc Medicine is led by a seasoned, collaborative team of scientists and industry experts committed to innovative programs that advance the frontiers of medicine. Disc Medicine values transparency, authentic communication, and scientific rigor and promotes a company culture in which differences are celebrated and all individuals are valued.
Interested in joining our team? Please contact us at firstname.lastname@example.org
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