Clinical trial management from start-up to close-out
Ethics committee submission and approval
This vital role serves as the primary point of contact to lead, manage, and coordinate the conduct of clinical trials from study start-up to close-out at a country level
Job Summary
This vital role serves as the primary point of contact to lead, manage, and coordinate the conduct of clinical trials from study start-up to close-out at a country level.
The successful candidate will be accountable for compiling and submitting documents to ethics committees while managing vendor activities and study budgets.
You will actively collaborate with cross-functional internal and external partners to ensure timely delivery and maintain the quality and scientific integrity of clinical trials.
Matching Summary
This vital role serves as the primary point of contact to lead, manage, and coordinate the conduct of clinical trials from study start-up to close-out at a country level.
Skills & Requirements
Must-have
ICH-GCP and local regulatory compliance
Clinical trial management from start-up to close-out
Ethics committee submission and approval
Vendor oversight including CROs and labs
Study budget planning and deviation management
Site contracting and payment process supervision
Cross-functional team leadership and collaboration
Nice-to-have
Strong site relationship building skills
Experience with EU Clinical Trials Regulation
Proven ability to drive study progress
Local cluster team engagement expertise
Risk mitigation activity leadership
Key Requirements
Doctorate degree OR Master's & 3 years experience OR Bachelor's & 5 years experience
Minimum 7 years work experience in life sciences or medically related field
4 years of biopharmaceutical clinical research experience
2-3 years experience leading local/regional or global teams
Must be a local/country expert with proven project management experience locally