Clinical Trial Manager (Senior)

The Clinical Trial Manager (CTM), in consultation with and support from Clinical Operations leadership, is responsible for all day-to-day operational aspects of a clinical study from setup through final report. The CTM coordinates the activities of other in-house and clinical team members (e.g., Clinical Trial Associates, Data Managers, Supply Chain, etc.), as well as external clinical vendors and/or consultants. The CTM also assumes the role of the in-house Lead Clinical Research Associate for a study, as needed. Specific responsibilities include, but are not limited to : * Lead and manage all operational aspects of assigned clinical trials (Phase 1–3), including CRO/vendor oversight, site management, study timelines, budgets and deliverables * Serve as the primary point of contact for internal stakeholders, CROs, and other external vendors for assigned trial(s) * Proactively identify risks, issues, and roadblocks, and implement data-driven solutions before they impact trial progress * Apply strong critical thinking to interpret complex clinical and operational issues, escalate as appropriate, and lead cross-functional problem-solving efforts * Monitor study progress using key performance indicators (KPIs) and metrics to ensure adherence to protocol, GCP, and regulatory requirements as well as the project budget * Be accountable for departmental quarterly metrics * Participate in protocol development, site selection, feasibility assessments, ICF review, and other essential documents * Collaborate closely with cross-functional partners including Regulatory, Program Management, Biostatistics, Data Management, and QA to ensure seamless execution * Lead the development of study tools, training materials, site communications, and trial management plans * Develop and manage clinical trial budget and facilitate contract review with Legal and vendor partners * Monitor CRO and vendor adherence to scope of work (e.g. confirmation of units consumed, oversight of milestone and deliverable schedule) * Participate in vendor, site and CRO audits as appropriate * Participate in site monitoring visits as necessary * Plan and present at investigator meetings, company, and other meetings as necessary * Develop internal tracking and reporting tools for reporting study status to leadership and facilitate internal and external project team meetings * Adhere to relevant company policies and SOPs, cGCP/ICH guidelines, QC/QA procedures, as well as relevant clinical regulatory requirements Qualifications include : * 5+ years of clinical trial operations experience in a biotech, pharmaceutical, CRO, clinical research site or related healthcare company * Experience working on a multi-phase early phase (Phase 1 & 2) clinical program * Cell therapy experience is preferred. * Regulatory Authority Inspection experience preferred * Robust understanding of the drug development process * Highly organized, outcome-oriented, self-motivated performance * Ability to analyze complex issues objectively, using relevant KPIs, and applying a data-driven mindset, to develop and recommend trial-related plans, mitigations, and solutions. * Ability to thrive in a fast-paced and evolving environment * High level of integrity, ethics, and discretion * Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills * Strong working knowledge of cGCP/ICH guidelines, and US and international clinical regulatory requirements * Strong written and oral communication skills * Comfortable navigating ambiguity and adapting quickly to shifting priorities * Excellent problem-solving and decision-making skills with a “roll-up-your-sleeves” mindset * Periodic travel related to project meetings and/or team meetings, may be required * Ability and willingness to travel domestically and internationally (10-20%) * Must be able to laugh and contribute to a positive work culture. Education: * Bachelor’s degree in a scientific discipline is required * Advanced degree or certification is a plus Note: This job description is written as a guideline to inform a current or prospective Stratus employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.