About this role
Job title: Clinical Trial Manager – Sponsor Dedicated
About the Role
Clinical Trial Manager – Sponsor Dedicated will oversee local-level management of sponsor-supported clinical trials from start-up through closeout. You will ensure compliance with sponsor SOPs, GCP, and local regulations while delivering end-to-end project management and on-time trial execution at the country level.
What You'll Do
- Provide operational oversight of assigned trials at the local level from start-up through closeout, ensuring end-to-end project management and on-time delivery.
- Ensure adherence to sponsor SOPs, WIs, policies, GCP, and local regulatory requirements.
- Prepare or contribute to high-level budgets and detailed budget proposals; participate in contract management including ESP contracts and change orders; ensure services are delivered per contract.
- Act as primary country-level contact, monitor progress against timelines, and oversee patient recruitment to meet target enrollment; develop local trial procedures, recruitment plans, contingency and risk management, and budget forecasting.
- Maintain and update trial management systems; analyze progress using management reports; support HA inspections and internal QA audits; escalate CAPA as needed.
- Contribute to site-level recruitment strategy and contingency planning with other functional areas.
- Assist in reviewing country-specific informed consent materials and manage site-specific informed consent forms in line with SOPs and applicable regulations.
What We're Looking For
- BA/BS degree; degree in health or science field.
- Minimum of 2 years local/regional trial management experience in pharma or CRO; prior experience as a Clinical Research Associate.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, SOPs, local laws/regulations, assigned protocols and protocol-specific procedures.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight stays as dictated by business needs.
- Excellent decision-making and strong financial management skills.
- Proficient in speaking and writing the country language and English.