Description
We are seeking a Clinical Research Manager to oversee local operational clinical trial activities in a country, ensuring compliance with ICH GCP and country regulations.
The successful candidate will have a significant impact on the delivery of country-specific trial commitments and objectives, and will serve as a customer-facing representative for our client.
Responsibilities:
- PERFORMANCE: Ensure performance and compliance for assigned protocols in a country, adhering to ICH/GCP and country regulations, client policies and procedures, quality standards, and adverse event reporting requirements (30%)
- MANAGEMENT: Serve as point of contact for assigned protocols, proactively driving execution and performance of deliverables, timelines, and results to meet country commitments (20%)
- QUALITY OVERSIGHT: Oversee quality and compliance in assigned protocols, perform quality control visits, and review monitoring visit reports (20%)
- EXTERNAL CUSTOMER FACING: Collaborate with functional outsourcing vendors, investigators, and external partners, and oversee country and site validations, site selection, and recruitment (20%)
- INTERNAL COLLABORATION and STRATEGY: Collaborate internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries, and support local and regional strategy development (10%)
Qualifications:
- University/college degree in life sciences or related field, or certification in a related allied health profession
- Minimum 6-8 years of clinical research experience
- Thorough knowledge of ICH Guidelines and GCP, and understanding of regulatory requirements
- Excellent communication and organizational skills
- Ability to work independently and in a team environment
Physical Demands/Work Environment:
- Client office as per assignment