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TMF Associate/Manager

Norwood, MA

Posted: 11/09/2018 Job Category: Clinical: Document Management Job Number: 2202

The TMF Associate/Manager is responsible for overseeing the daily document management activities ensuring the integrity of the Trial Master File (TMF). The TMF manager will provide oversight and management of the end-to-end activities involved in administering the TMF. S/he will be required to work collaboratively with group members and contribute to positive team relationships, both locally and globally. This role will lead initiatives and serve as a subject matter expert in TMF Operations.

RESPONSIBILITIES INCLUDE:
  • Coordinating QC reviews of study TMFs to ensure they are of the highest quality and inspection ready, and meet compliance specifications according to regional regulations and ICH guidelines;
  • Managing the activities associated with the TMF business process, including continuous improvement activities and metrics, and archiving;
  • Assisting with the oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training;
  • Liaising with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF
  • Manage quality control reviews of study TMFs and perform quality control reviews to ensure the TMF is inspection ready
  • Provide feedback to project teams and /or management for the correction and resolution of document quality issues, TMF completeness and timely submission of documents to the TMF
  • Lead the activities associated with TMF management and archiving, including assisting in oversight of the eTMF vendor, developing business processes, coordinating TMF setup, training and resolution of eTMF queries.
  • Direct the activities associated with assigned Lead process; train and mentor staff as needed in assigned Lead process; generate overall metrics associated with process
  • Manage the local and global activities related to archiving of TMF documents
  • Liaise with other functional areas and CRO stakeholders to ensure consistent processes and procedures for the management of the TMF.
  • Facilitate the writing or update of departmental SOPs, WIs, job-aids and guidelines as needed.
  • Supervise one or more Associate/Sr. Associate and/or Contractor
  • Work closely with other Clinical Operation, the eTMF vendor, CRO partners and other functional area groups

REQUIREMENTS / QUALIFICATIONS:
  • Education to Bachelor of Science level or equivalent, preferably in a scientific discipline
  • Demonstrated experience in the pharmaceutical industry, preferably in regulatory operations or clinical development/operations
  • Experience with Clinical Document Management, TMF, and/or Clinical Quality Control desired
  • Detailed knowledge of domestic and international regulatory requirements (including ICH, EMA, and FDA guidelines)
  • Strong knowledge of key clinical trial documents (e.g., IBs, ICFs, CRFs, Protocols, regulatory approval documents)
  • Solid understanding of the clinical development process
  • Knowledge/understanding of technologies to support document collection and archiving
  • Must have strong verbal, written and interpersonal communication skills, especially needed to work in and effectively manage a cross-functional team
  • Ability to drive cross-functional projects with conflicting priorities
  • Ability to work with individuals from a wide range of cultures
  • Must be very detail oriented and possess excellent organizational and time management skills
  • Ability to work both independently and as part of a team, both within direct and matrix environments
  • Proficient computer skills, especially using MS Office

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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