Clinical Operations Manager %28Clinical Trial Manager%29

The Clinical Operations Manager is a hands-on leader responsible for the end-to-end management of clinical trials.

This is a key position for someone who wants full ownership of a global clinical study end-to-end — from protocol development and operational strategy through study start-up, execution, database lock, and CSR delivery. You will work under and closely with the Director of Clinical Development and collaborate with cross-functional colleagues in a highly dynamic, thoughtful, and execution-oriented environment.

Responsibilities

Lead the Full Clinical Trial Lifecycle

· Drive operational planning and study execution for global clinical trials, ensuring timely, high-quality delivery from protocol to CSR.

· Lead start-up activities, including feasibility, site selection, regulatory planning, SIV readiness, and operational timelines.

· Maintain study oversight across conduct, monitoring, safety reporting, deviations, and close-out.

Clinical Trial Planning & Study Start-Up

· Lead operational planning for clinical studies, including timelines, budgets, enrollment strategy, risk assessments, and vendor/service needs.

· Support protocol development, ICF review, operational feasibility, and site selection strategy.

· Oversee country and site start-up activities, including regulatory submissions, contract negotiation tracking, and readiness activities.

CRO & Vendor Management

· Lead CRO and vendor selection processes %28RFPs, bid defense, scoring, and contract oversight%29.

· Manage day-to-day CRO / vendor performance, deliverables, KPIs, timelines, and quality oversight.

· Implement corrective and preventive actions %28CAPA%29 when performance deviates.

· Ensure proper coordination of central labs, imaging vendors, specialty labs, ePRO/EDC providers, IP logistics vendors, and additional study partners.

Study Execution & Site Oversight

· Oversee all site-facing activities: study initiation, monitoring plans, enrollment tracking, deviation management, IP accountability, and site compliance.

· Build strong relationships with investigators and site staff to ensure high engagement and high-quality data.

· Review monitoring reports, action items, site communications, and enrollment metrics.

· Ensure effective delivery of trial materials %28IP, lab kits, manuals, training materials%29.

Data Quality, Reporting & Documentation

· Oversee data integrity, query management processes, and coordination between Clinical Operations, Data Management, and CRO partners.

· Lead trial-level risk management, issue escalation, and mitigation planning.

· Ensure accuracy and completeness of Trial Master File %28TMF%29 and operational documentation.

· Drive database lock, medical review support, and CSR completion.

Governance & Representation

· Represent the sponsor in internal and external meetings:

· Provide operational input to cross-functional teams %28Regulatory, Safety, CMC, Biometrics, Medical%29.

· Maintain strict adherence to ICH-GCP, local regulations, SOPs, and inspection readiness requirements.

Qualifications:

· Bachelor’s degree in life sciences or related field; advanced degree preferred.

· Minimum 5 years of direct clinical study management experience %28or at least 5 studies%29 is a must, with proven ability to lead a clinical study independently from start to finish %28protocol → CSR%29, preferably as a sponsor CTM.

· Proven project management skills, including budgeting, timeline development, risk management, and cross-functional coordination.

· Strong experience with CRO and vendor oversight, including selection, contracting support, governance, and performance tracking.

· Experience in a biotech or fast-paced startup environment is an advantage.

· Familiarity with EDC, CTMS, eTMF, and general clinical data management processes

· Familiarity with clinical data management processes

· Advantage: experience in rare disease clinical trials, dermatology related indications and advanced phases %28Phase 2–3%29.

· Excellent communication, leadership, and interpersonal skills with a collaborative mindset.

· High proficiency in English %28written and spoken%29.