Obsidian Therapeutics · 8 hours ago
Clinical Trial Manager
Cambridge, MA
Full-time
Onsite
Mid, Senior Level
$114K/yr - $140K/yr
5+ years expObsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. They are seeking a Clinical Trial Manager to oversee early phase cell therapy oncology clinical trials, ensuring compliance with regulations and facilitating collaboration among study teams.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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%
Preference to West Coast or Boston Area, if in either location occasional in office time is expected
Preferred
experience working from sponsor side and overseeing CRO and other external vendor management
Familiarity with GxP inspection preparation
Benefits
Annual incentive bonus as a percentage of actual base salary
Long-term incentives in the form of employee stock options
Comprehensive medical, dental, and vision coverage
Company contributions to health savings and retirement accounts
Ample paid time off
Access to wellness programs
Rich career growth opportunities
Company
Obsidian Therapeutics
Obsidian Therapeutics is a developer of a next-generation cell and gene therapies created to extend adoptive immunotherapy.
51-200 employees
H1B Sponsorship
Obsidian Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$325MKey Investors
Wellington ManagementThe Column GroupGoogle Ventures
2024-04-03Series C· $160.5M
2021-09-09Series B· $115M
2017-12-06Series A· $49.5M
Leadership Team
Madan Jagasia
Chief Executive Officer
Kirsten Kester
Senior Vice President, Business Development
Recent News
2026-01-13
DelveInsight Business Research LLP
2025-10-14
Company data provided by crunchbase