- Company Name
- GForce Life Sciences
- Job Title
- Clinical Trial Manager
- Job Description
-
**Job Title**
Clinical Trial Manager
**Role Summary**
Lead and oversee all aspects of early‑stage clinical trials, ensuring compliance with regulatory standards (FDA, EMEA, ICH‑GCP) and alignment with business objectives. Responsible for strategy, budget, timeline, operational execution, and cross‑functional collaboration across global teams.
**Expactations**
- Manage end‑to‑end trial lifecycle from Start of Development to Proof of Concept for assigned indications.
- Maintain inspection readiness and regulatory compliance.
- Drive efficiency and quality improvements in processes and performance metrics.
- Deliver projects within scope, time, and cost constraints.
**Key Responsibilities**
- Develop clinical strategy, methodology, and evidence plans for assigned assets.
- Define and execute site selection, recruitment, and enrollment plans to meet targets.
- Oversee budgeting, financial monitoring, and adherence to ICH‑GCP and local regulations.
- Produce and review regulatory documents (Investigator Brochure, Study Reports, Safety Updates, Briefing Books, Dossiers).
- Coordinate with Clinical Trial Supply on comparator sourcing and product management.
- Lead data management support: database design, user test, edit checks, data cleaning, and monitoring guidelines.
- Draft and update SOPs, process maps, and training materials for CTAs and related staff.
- Collaborate with global project managers, technical leads, and regulatory affairs to ensure alignment.
- Identify and implement process improvements to enhance reliability, efficiency, cost, and quality.
**Required Skills**
- Strong knowledge of FDA, EMEA, ICH‑GCP, and clinical safety regulations.
- Expertise in patient recruitment, non‑compliance management, and budgeting.
- Proficient in creating clinical protocols, SOPs, and regulatory submissions (NDA ready).
- Excellent stakeholder communication and cross‑functional leadership.
- Analytical mindset for performance metric evaluation and process optimization.
**Required Education & Certifications**
- MSc or PhD in Basic Sciences or related field.
- Minimum 5+ years’ experience in Clinical Operations within biotech, pharma, or CRO.
- Experience leading global trials, preferably outside U.S./EU/Asia/Americas regions.
- Demonstrated success in business process transformation and culture change initiatives.