Position can be Contract, Contract to Perm or Permanent (imminent need for a Contractor to be in place asap)!  

Reporting to the Sr. Director, Clinical Excellence Operations the Senior Manager/Associate Director, Records Management will   be responsible for expertise, oversight, implementation of systems and process improvement and training related to the trial master file (TMF) and eTMF systems, and other clinical trial documentation. The incumbent is responsible for records management activities across all therapeutic areas of development at Company. The Associate Director of Records Management will provide direct management and leadership for individuals in the records management team. The incumbent will ensure GCP compliance and inspection readiness related to clinical records management within the clinical operations department.

Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

·       Provide leadership to the records management team fostering a collaborative team culture while ensuring goals and timelines are met with quality, in compliance with SOPs and regulatory guidelines. Identifies and/or anticipates risks and plans accordingly for mitigation and escalates issues to management as necessary.

·       Acts as the clinical operations TMF/eTMF subject matter expert by providing expertise, best practices related to clinical records management, system implementation and training development.

·       Provide management and oversight of the TMF/eTMF, including implementation of systems, oversight plans, process documents, tools and templates related to TMF/eTMF.

·       Perform routine sponsor oversight reviews of study TMF/eTMF to ensure compliance to quality records management deliverables across the entire Company Therapeutic profile.

·       Management of the CRO/Vendors and risk mitigation strategic input to ensure goals and deliverables are met with quality in the contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.

·       A contributing member of cross-functional study teams ensuring GCP compliance and implementation of the TMF oversight plan quality goals and making sure timelines are met, incompliance of SOPS and regulatory guidelines, while fostering a collaborative team culture.

·       Assist with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training.

·       Support of Clinical Operations projects, infrastructure, training, and processes (e.g. SOP development and review, management of clinical systems, oversight of clinical metrics tracking and reporting), inspection readiness efforts and audit-ready Trial Master Files reviews (internal and at CRO).

·       Management of the eTMF migration process when the TMF is held by an external vendor to ensure the delivery of a complete and accurate TMF.

·       Travel required: up to 10% (for business meetings at Company office, eTMF audits at CRO/Vendors, and industry conferences)

Qualifications:

·       BA/BS degree in Health or Life Sciences required, advanced degree preferred.

·       A minimum 5-6+ years (Sr. Manager)/8+ years (Associate Director) of relevant experience in Clinical Operations roles within the Pharmaceutical and/Medical Device Industry, with heavy concentration within clinical trial management and monitoring.

·       A minimum of 5+ years’ experience with trial master file/records management, oversight, maintenance, document review and QC is required

·       A minimum of 2+ years of experience as a manager/leader

·       Health authority inspection experience is preferred

·       Exceptional collaboration, communication, and interpersonal skills

·       Demonstrated ability to effectively manage external vendors & CROs

·       Advanced proficiency in Microsoft Office and Microsoft Project

·       Reliable, self-motivated, team player

·       Detail oriented with excellent organizational skills

·       Ability to effectively manage multiple tasks and competing priorities