Clinical Trial - Global Study Lead Direct Hire MA
Job ID: 16379 Direct Hire MA
Our client is a mid-sized, public, therapeutics company in the Cambridge area and they are growing! They are seeking an experienced Clinical Trial Global Study Lead (Associate Director level or title commensurate with experience) to plan, budget, initiate and execute one or more large, complex, global clinical studies and implement appropriate standards and processes to ensure clinical study quality.
The main function of this role is to manage and lead the operations of global clinical studies to ensure completion in compliance with applicable GCP/ICH guidelines and regulatory requirements.
Responsibilities include but are not limited to;
• Develop and manage MS Project timeline and the direction, planning and execution of the clinical trials including RFP process and vendor selection.
• Review and approve investigational sites based on complete site assessment by CRO, contracts and budgets negotiations with clinical sites and vendors, and coordination of investigator/study management meetings.
• Maintain oversight of CROs and be responsible for the quality of CRO work through regular review and evaluation throughout the duration of the trial.
• Identify and report potential issues timely and effectively and implement corrective actions. Review and approve CAPA plans at individual site and across studies.
• Participate in internal/external study related audits.
• Provides oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses are developed and executed.
• Reviews critical study documents created by CRO including informed consent forms, study conduct documents such as Study Operations Manual (s), training material, study tools etc.
• Participates in protocol development and review of CSR.
• Works with clinical supplies on study drug quantities and packaging requirements.
• Mentors indirect reports and trains team members/vendors as needed.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BA/BS with 7-10 or MA/MS with 5-7 years of direct multi-trial clinical study management experience in biotech/pharma. Must have experience with all stages of clinical study management (start-up, maintenance, close-out) for Phase II/III global studies. Must be able to travel up to 20%, domestically and internationally.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.