Note: The job is a remote job and is open to candidates in USA. SRT Therapeutics is seeking an Associate Director, Clinical Operations, to lead the operational execution of multiple clinical studies across their development programs. The successful candidate will ensure clinical trials are executed according to timelines, budget, quality standards, SOPs, GCP, and corporate objectives.
Responsibilities
- Own all operational aspects of assigned clinical trials, including oversight of CROs and external vendors
- Lead or support cross-functional study teams to ensure successful planning and execution of clinical trials
- Provide regular study updates to internal stakeholders, including enrollment, protocol deviations, eligibility, safety reporting, and overall study performance
- Develop, manage, and track study budgets in partnership with Finance, including forecasting and accruals
- Author and maintain study operational documents, including monitoring plans, deviation management guidelines, and operational procedures
- Contribute to the development and review of key study documents, including clinical protocols, informed consent forms, pharmacy manuals, eCRF completion guidelines, eTMF structures, and operational guidance documents
- Monitor operational study metrics, including Investigational Product accountability, protocol deviation, outstanding action items and query aging and resolution
- Identify operational risks and implement mitigation strategies to maintain study quality, compliance, and timelines
- Review and approve monitoring visit reports for quality, completeness, and protocol compliance
- Develop and deliver Clinical Operations training materials, including CRA onboarding, site staff training, investigator meetings, and Site Initiation Visits (SIVs)
- Support clinical data review, cleaning, and reconciliation across EDC, ePRO, central laboratories, and other third-party vendors to facilitate timely database lock
- Support site feasibility and selection by evaluating investigator experience, site infrastructure, enrollment potential, and protocol fit
- Ensure timely collection, review, and filing of essential documents within the eTMF while maintaining inspection readiness
- Foster strong working relationships with internal cross-functional teams and external partners
Skills
- Bachelor's degree in Life Sciences or a related discipline
- Minimum of 10 years of progressive clinical trial management experience within biotechnology, pharmaceutical, or CRO environments
- Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements, with focus on quality and inspection readiness
- Demonstrated success managing clinical trials from study start-up through close-out with experience overseeing global, multi-site clinical trials and CRO partnerships
- Experience in the drug development process, including trial design, planning, and management
- Experience in Inflammatory Bowel Disease (IBD) clinical trials is highly preferred
- Proficiency with CTMS, eTMG platforms, IRT and EDC systems and safety databases
- Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and Microsoft Project and/or Smartsheet
- Exceptional organizational and project management skills with the ability to manage multiple priorities simultaneously
- Excellent communication, collaboration, and influencing skills
- Comfortable working with ambiguity, changing priorities, and the pace of a growth-stage biotech company
- Strong sense of ownership, accountability, and execution
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