Job Description

Description

The clinical operations in the Department of Early Clinical Stage Development plays a central role in the Phase 1 clinical development at Alkermes. He/She will lead operations across all future clinical sites to ensure operational and the organization’s objectives are met. The candidate will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.

Role and Responsibilities

• Responsible for developing strategy, and methodology of clinical operations programs.
• Responsible to ensure clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
• Ensures excellence, planning, oversight, and delivery of clinical programs/trials prior to Start of Development until Proof of Clinical Principle/Concept within assigned indication or given asset in a priority disease area with focus on speed and value as Medicine Excellence goals.
• Oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines.
• Provide operational and strategic input on training materials, program specific standards, clinical development plans, and clinical sections of regulatory documents (e.g., Investigator Brochure, clinical study reports, safety updates, briefing books, submission dossiers).
• Ensures timely execution excellence input into various documents, incl asset evidence plan and clinical trial protocols.
• Responsible for collaborating with Clinical Trial Supply Unit in determining a comparator sourcing strategy if applicable.
• Drive site selection and subject recruitment programs to deliver study enrollment targets.
• Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
• Participates in SOP development, process mapping, training of CTAs, and other departmental activities.
• Partner and liaise with internal team members across the globe, which includes: technical leads in multiple functional areas, project management, and regulatory affairs

Minimum Education & Experience Requirements:

• M.S or Ph.D in basic sciences with 10+ years’ experience of Clinical Operations experience at biotechnology or pharmaceutical company or CRO.
• Ability to look for and champion more efficient and effective methods/processes of delivering Clinical operations focusing on key performance metrics around reliability, efficiency, cost and quality.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
• Experience leading global trials outside the US/UE/ASIA/Americas is preferred.
• Advanced experience with patient recruitment, non-compliance, safety, document management, investigational product, and budget management.
• Demonstrated experience in successful planning and implementation of clinical trial operations.
• Experience developing clinical protocols, SOPs, Clinical Study Reports, and other documents to support New Drug Application (NDA) on time, within budget, and in compliance.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.

Required / Desired

• 5+ years of experience in clinical trials

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