Clinical Trial Manager

Obsidian Therapeutics•Cambridge, MA

About The Position

We're seeking a highly organized, hands-on, collaborative, and experienced Clinical Trial Manager to oversee our early phase cell therapy oncology clinical trials (targeting metastatic melanoma and non-small cell lung cancer). You will facilitate collaboration with internal and external study teams to ensure patient recruitment, timelines, quality standards, Good Clinical Practices and applicable regulations are being met throughout all stages of the study. As part of our Clinical team, you’ll play a vital role in achieving Obsidian’s vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115 engineered to make TILs more effective for more patients. We are seeking an individual who takes ownership and brings knowledge and experience to oversee our clinical studies, anticipate and mitigate risks, exercise good judgement, and help us build an excellent clinical operations practice. This role will begin as an individual contributor, with potential to lead a team as our studies progress. This is a unique opportunity to contribute to advancing a novel cell therapy that has the potential to become a meaningful option for patients with advanced or metastatic melanoma and other solid tumors. Supported by blue chip investors, field-leading advisors, best-in-class partners, and an experienced team, you'll be part of a dynamic, innovative, passionate, and collaborative team.

Requirements

BS/BA/RN Degree with 8+ years of experience in a life science or a health-related field is preferred.
Minimum of 5+ years working on phase I-IV clinical studies, ideally at a sponsor, CRO or clinical study site in management of oncology, rare disease, or cell/gene therapy trials
Strong understanding of regulatory (e.g., ICH-GCP, FDA and EU regulations) and Compliance requirements
Biotech/biopharma sponsor experience, including oversight of CROs in multi-site studies.
Strong understanding of clinical study data review and data management processes, including Data Monitoring, protocol deviations, and overall data integrity of studies.
Initiative to recognize gaps and opportunities for improvement and develop solutions.
An ability to manage multiple responsibilities in parallel in a dynamic and fast paced environment with high standards.
Exceptional attention to detail, organization, and record-keeping.
Excellent oral and written communication skills
Analytical thinking; proactive and intuitive about clinical trial issues/risks
Exceptional risk mitigation and problem-solving skills
Proficient in MS Office Suite
Ability to travel up to 20%

Nice To Haves

experience working from sponsor side and overseeing CRO and other external vendor management
Familiarity with GxP inspection preparation

Responsibilities

Support all clinical aspects of clinical trial operations from site selection and qualification, through study initiation to close out ensuring study deliverables are met on time and all relevant metrics are tracked and reported.
Contribute to the development of study execution plans, partner with internal and external teams (Regulatory Affairs, Program Management, CMC, CRO, investigators/site staff, specialty labs, etc.), identify and mitigate risk throughout the study lifecycle.
Assist in development of study budget, review and approve clinical invoices, and oversee expenses to ensure all fall within approved budget.
Oversee study start up and site initiation activities and ensure clinical research staff including CRO, CRAs, sites and other contract personnel receive study-specific training and leadership.
Contribute to writing clinical protocols, study related documentation (ICF template, CRFs, CRF Completion Guidelines Monitoring Plan, Laboratory Manual, TMF plan, Pharmacy Manual, etc.) and regulatory documents such as INDs.
Prepare and review site study documents (e.g. site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
Ensure the Trial Master File (TMF) documentation is complete and up to date.
Oversee laboratory sample management and ensure clinical supplies are available for sites.
Participate in quality assurance activities (review of protocol deviations, site specific CGP issues, review of monitoring reports, etc.) and ensure audit-ready condition of clinical trial documentation including central clinical files/Trial Master Files.
Oversee clinical monitoring activities ensuring compliance with ICH/GCP and applicable regulations.
Assist in developing and managing an ongoing data review plan to ensure detection of data trends and to ensure study objectives are met.
Prepare and present project briefings as required. Plan and facilitate study-specific meetings with CRO or other vendors (e.g., Study Management Meetings, investigator meetings, etc.).
Participate in selection and management of external vendors, develop vendor specifications, and review vendor reports, budgets, and metrics.