This role will be a highly qualified and motivated individual who will own the TMF Management and Inspection Readiness group. The role will provide TMF SME expertise across all therapeutic areas and research phases and will be required to work closely with R&D teams and Contract Service Providers (CSPs) as clinical trials are crafted and conducted.

Primary Responsibilities

• Is responsible for resource planning, including consultants, to support TMF and inspection readiness including TMF management vendor to ensure compliance with GCP and industry standards.
• Provide leadership and oversight for the Trial Master File (TMF) process, including the TMF related controlled documents/templates, ensuring compliance with regulatory requirements and organizational standards.
• Review TMF metrics across programs, analyzing TMF performance indicators and identifying trends or deviations from Key Performance Indicators (KPIs).
• Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.
• Serve as a key point of contact for TMF-related inquiries and provide SME guidance to internal stakeholders on TMF processes and requirements.
• Lead the development and maintenance of comprehensive inspection readiness plans, tools, reference materials, and provide guidance to staff on preparation efforts for health authority inspections.
• Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections.
• Assist the liaison between Acadia and regulatory agencies, facilitating communication and information exchange during inspections and providing leadership to staff in inspection preparation and response strategies.
• Lead and share TMF best practices with internal and external stakeholders, as appropriate.
• Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.
• Other responsibilities as required.

Education/Experience/Skills

Bachelor’s degree in the life sciences or related field; Advanced degree preferred. Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 4 years TMF experience in a leadership and oversight role. Health Authority inspection experience is required. An equivalent combination of relevant education and experience may be considered.

• Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.
• Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.
• Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.
• eTMF experience required; Veeva Vault eTMF/CTMS experience preferred.
• Demonstrated problem-solving abilities, with strong attention to detail.
• Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating stakeholders to achieve goals.
• Demonstrated analytical abilities and proficient planning and negotiation skills.
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output.
• Demonstrated technical, administrative, and project management capabilities.
• Ability to travel approximately 25% of the time.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

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