• Direct and oversee clinical trials execution to ensure compliance with regulatory requirements, adequacy of data acquisition and management, and ensure timely completion of clinical studies.
• Implement all logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.).
• Monitor, communicate and manage budgets for clinical trials; negotiates fees with clinical sites and service providers.
• Nurtures, promotes, and speeds the development of high-quality high-performing study sites to support clinical trials.
• Has broad experience selecting, managing, troubleshooting and negotiating with (CRO) vendors.
• Evaluates, refines, and makes recommendations for various operational constructs for study execution.
• Cultivates a sustained and synergistic partnership with clinical investigators and institutions focused on science and clinical excellence.
• Leads strategies for patient recruitment and retention in clinical trials.
• Interacts internally and externally with executive level management requiring negotiation of complex matters.
• Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs.
• Travel is required (approximately 30%), which may include international travel.
• Other tasks as assigned.
Bachelor’s degree in the life sciences or related field. Advanced degreepreferred.
• At least 10 years of related experience. with significant late-stage and ex-US clinical trials experience. At least 6 years’ proven experience in a leadership and people management role.
• Practical experience in clinical trial strategies, methods and processes; deep knowledge of clinical trial execution.
• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output, including cross-functional understanding related to drug development.
• Prior experience managing third parties and external service providers (including ex US) and consultants is a must
• Good judge of risks and a keen ability to analyze options and manage outcomes.
• Familiarity of Regulatory Affairs as applicable to clinical data and report filings.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
• A good understanding of GCPs.
• Well versed with the latest trends in the clinical trial industry.
• Possess a strong commitment to quality and accuracy as a self-starter and a team-player in a fast-paced, start-up like environment.