Top 3 Must Have Skill Sets:
• 6+ 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 oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
• Experience of collaborating and leading cross-functional global teams in a matrix environment
The primary point of contact to lead, manage and co-ordinate the conduct of Phase 1/1b clinical trials from study design to close out at a global level in accordance with ICH-GCP.
Assignment Duration: 6-12 months
Location needed (or remote): Remote
• Lead the Clinical Study Team to drive effective decision making
• Develop early phase clinical operation strategy and contributes to the strategic scenario planning in clinical development plan
• Oversee the quality and scientific integrity of clinical operations for early development studies at a global level
• Lead study level planning of the overall clinical operation, execute day-to-day operations of clinical trial at a global level and resolve issues escalated by the local study team
• Collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
• Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Manage vendors to the required standards
• Contribute to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials,
safety and regulatory documents, and clinical study report.
"This posting is for Contingent Worker, not an FTE"