MINIMUM REQUIREMENTS

• Doctorate degree OR
• Master’s degree & 3 years of directly related experience OR
• Bachelor’s degree & 5 years of directly related experience OR
• Associate’s degree & 10 years of directly related experience OR
• High school diploma / GED & 12 years of directly related experience
• Advanced knowledge of global clinical trial management
• Fluency in local language and business English

PREFERRED REQUIREMENTS

• Minimum 2-3 years’ experience of leading local/regional or global teams
• Minimum 2-3 years’ clinical trial project management experience
• 7 years’ work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
• Must be a local/country expert with identifiable project management experience locally
• Build strong site relationships as well as other local relationships to ensure end to end study delivery is met.

Knowledge

• Local knowledge / expertise of regulatory environment, study start up process and associated timelines etc.
• Clinical trial processes and operations
• Extensive knowledge of ICH/GCP regulations and guidelines
• Global to Local project management with oversight of study deliverables
• Program management including oversight of study deliverable, budgets and timelines
• Time, cost and quality metrics including key performance indicators (KPIs)
• Relevant Therapeutic knowledge is preferred

• Primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up (COLA) to close out (CSR/Archival) at a country level in accordance with ICH-GCP and other applicable local regulations
• Maintain the quality and scientific integrity of clinical trials at a local/country level
• Actively collaborate with cross functional internal and external stakeholders to ensure timely execution, budget execution of clinical trial deliverables within the local country
• Must be a local/country expert with proven project management experience locally
• Empowered decision maker and must have country/site knowledge
• Must be a protocol expert to support sites proactively with questions
• Must be a team player who can interact locally and globally to ensure strategy is understood and followed
• Must be able to build strong site relationships as well as other local relationships to ensure end to end study delivery is met.