The Clinical Operations Manager will lead end-to-end operational execution of Rapalogix Health's clinical study portfolio, currently comprising approximately 10 active studies. This individual brings deep expertise in non-interventional and topical product research, will own the full lifecycle of study operations from protocol development and vendor selection through site management, data integrity, and claim substantiation.
The right candidate combines rigorous scientific and regulatory knowledge with the cross-functional agility to manage technical timelines alongside a fast-moving commercial organization. You are comfortable operating with autonomy, managing external partners, and delivering study outputs that meet both clinical and marketing standards.
Trial Design & Protocol Development
- Lead the design and development of clinical study protocols in alignment with R&D and commercial objectives
- Define study endpoints, assessment tools, and methodology appropriate to topical and dermocosmetic product evaluation
- Ensure protocol design meets GCP/ICH guidelines and supports downstream efficacy claim substantiation
- Collaborate with R&D leadership and external scientific advisors to refine study design and research questions
Vendor, CRO, and Site Management
- Identify, evaluate, and manage CROs, clinical sites, and third-party vendors across the study portfolio
- Negotiate contracts, scopes of work, and budgets with external partners
- Oversee site initiation, training, and ongoing performance monitoring to ensure quality and timeline adherence
- Serve as the primary operational point of contact for all CRO and site relationships
Safety & Adverse Event Oversight
- Monitor adverse events and protocol deviations.
- Ensure timely safety reporting and documentation.
- Partner with investigators and CROs to maintain participant safety standards.
Data Management & Clinical Reporting
- Oversee clinical data review, query resolution, and database quality checks.
- Collaborate with biostatisticians and data analysts to ensure accurate interpretation of study results.
- Review clinical study reports (CSRs), final reports, and study summaries.
- Translate study outcomes into claim-support packages and scientific evidence documents.
Clinical Documentation, Quality & Compliance
- Own the development, review, collection, and maintenance of all essential clinical trial documentation, including Case Report Forms (CRFs), source documentation, Investigator Site Files (ISFs), Trial Master Files (TMFs), Investigator Brochures (IBs), informed consent forms (ICFs), delegation logs, training records, and regulatory documents.
- Ensure all Principal Investigator (PI) qualifications, licenses, CVs, training records, financial disclosure forms, and site regulatory documents are complete, current, and inspection-ready.
- Maintain TMFs in accordance with GCP/ICH requirements and company SOPs, ensuring accuracy, completeness, version control, and audit readiness throughout the study lifecycle.
- Conduct periodic quality reviews of study documentation and collaborate with CROs and sites to resolve documentation gaps, protocol deviations, and compliance issues.
- Support sponsor audits, site audits, and regulatory inspections by ensuring all essential documents are organized, complete, and readily accessible.
Post-Market Clinical Research & Investigator-Initiated Studies
- Planning and execution of post-market clinical studies, real-world evidence programs, and observational research to support product lifecycle management, claim expansion, physician adoption, and long-term evidence generation.
- Evaluate, support, and oversee Investigator-Initiated Studies (IITs) in collaboration with academic investigators, dermatologists, and key opinion leaders (KOLs), ensuring scientific rigor, appropriate governance, and alignment with strategic research objectives.
