Clinical Trial Manager/Senior Clinical Trial Manager

Job description

The Senior/Clinical Trial Manager will be responsible for managing and executing operational aspects of assigned clinical trials, from study start-up to close-out, with a focus on autoimmune studies. This individual will be instrumental in managing and overseeing CROs, study vendors, and clinical trial sites, while partnering with key internal stakeholders to ensure clinical trial deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This position reports directly to the Senior Director of Clinical Operations and serves as an integral member of the Clinical Operations team, contributing to the development of trial strategy, executing initiatives, and ensuring the highest standards in operational delivery. This is a great opportunity to make a meaningful impact in a fast-paced, mission-driven biotech environment. ### ESSENTIAL FUNCTIONS AND RESPONSIBILITIES - Support the successful execution of clinical trials from protocol concept to clinical study report in support of complex autoimmune programs. - Prepare and maintain study-related files and documentation to ensure inspection readiness. - Organize and lead study and departmental meetings, including minute-taking and document archiving. - Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings). - Ensure team compliance with study-specific training and perform TMF reviews for completeness. - Support clinical sites in preparation for audits and inspections. - Assist with budget management and day-to-day clinical operations in compliance with SOPs, ICH/GCP, and regulatory requirements. - Track subject and site activity/metrics and perform quality checks across study components. - Proactively identify and escalate issues related to functional deliverables. - Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation. - Collaborate with CROs to ensure timely collection and archiving of TMF documents. - Coordinate with regulatory affairs on essential document submissions. - Support study close-out activities including TMF and drug reconciliation and CSR readiness. - Communicate effectively with study team members and work closely with Clinical Trial Managers and/or Asset Leads. - Participate in process improvement and quality initiatives related to study execution. - Other duties as deemed necessary. ### REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES - Bachelor’s degree with at least 5 years (CTM) or 8 years (Sr. CTM) of hands-on clinical trial experience, preferably within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered. - Demonstrated experience in complex autoimmune clinical trials, including trial set-up, monitoring, and close-out. - Strong working knowledge of ICH/GCP regulations. - Proficiency with electronic systems such as eTMF, CTMS, EDC, etc. - Ability to work independently with minimal oversight and thrive in a collaborative team environment. - Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset. - Excellent interpersonal, written, and verbal communication skills. - Proficiency in MS Office and comfort with technology. - Minimal travel required (0 to 5%).