Description
We are seeking a Clinical Trial Manager – Sponsor Dedicated to provide management of a clinical trial(s) at a local level. As a Clinical Trial Manager, you will be responsible for the operational oversight of assigned project(s) at the local level for end-to-end project management from start-up through to closeout activities.
Responsibilities:
- Adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), and local regulatory requirements.
- Prepare or contribute to high-level budget estimates and detailed budget proposals, and ensure overall contract management.
- Act as primary company contact for assigned trials at the country level, ensuring local/country teams track project progress and monitor patient recruitment rates.
- Drive study compliance by maintaining and updating trial management systems, using study tools and management reports to analyze trial progress.
- Contribute to site-level recruitment strategies and contingency planning, and participate in preparation for and conduct of Health Authority (HA) inspections and internal Quality Assurance audits.
- Contribute to patient understanding of protocol and patient safety by reviewing country-specific informed consent forms.
Requirements:
- BA/BS degree in a health or science-related field.
- Minimum of 2 years of local/regional trial management experience in the pharmaceutical industry or CRO, and previous experience as a Clinical Research Associate.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols, and associated protocol-specific procedures.
- Strong IT skills in appropriate software and company systems.
- Excellent decision-making and financial management skills.
- Proficiency in speaking and writing the country language and English.