• Sr. Trial Master File Specialist

    Category Clinical Operations
    ID
    2019-1300
    Job Location
    US-MD-Rockville
    Type
    Regular Full-Time
  • Overview

    MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

     

    The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

    Summary of Position

    The Senior Trial Master File (TMF) Specialist is responsible for ensuring that MacroGenics studies have comprehensive and quality TMFs ready for audits and inspections according to MacroGenics processes.  Support, consult, and coordinate with each study team for confirming the structure and plan for the TMF including but not limited to the set-up of the study structure in the eTMF, study team assignments within the eTMF, confirm QC content is completed according to plan, and oversee closure and final archive of the study eTMFs.  Act as the eTMF system SME and administrator.  

     

    Responsibilities and Job Duties

     

    • Support, consult and provide TMF guidance to the TMF accountable function(s) during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.  Lead, as assigned, cross-functional TMF oversight through the life cycle (planning, set-up, oversight, closeout, archival) of the study TMF.
    • Ensure MacroGenics cross-functional eTMF business process and operating model is followed for each study and determine differences from standard TMF structure is documented. 
    • Oversee eTMFs are ready for audit/inspection purposes by ensuring there is a study specific TMF plan. 
    • Manage the eTMF system as an administrator ensuring study TMFs are built according to the specific study architecture for inputs including: country and site objects; vendor and account objects; study team assignments; baseline milestones and baseline expected document lists.  
    • Serve as main subject matter expert for the eTMF system and identifies areas for continuous improvement for management of the system. 
    • Provide input to departmental operating procedures, work instructions, training materials, systems, and tools.
    • Work with the Audit and Inspection Readiness team, as needed, with a focus on preparing and supporting study teams for GCP and pre-approval related inspections on the study TMF compliance and completeness.
    • Uploads, maintains and reconciles study documents in the Trial Master File (TMF). Maintains a naming and filing guide
    • Performs quality check of documents uploaded by Clinical Operations/CRO’s, runs eTMF reports, as required.
    • Responds to inquiries regarding eTMF management and contents
    • Performs and completes eTMF study reviews, other study document-related and general administrative tasks as required by the study teams, the Directors or the Vice President of Clinical Operations
    • Attends departmental and study-specific meetings and discussions, as required
    • Actively involved in set-up and training for the internal or external team members, as applicable
    • Maintains effective communication with project teams, CRO staff, and eTMF vendor personnel throughout study start-up, maintenance, and close-out

    Qualifications

    Education and Experience

    • Bachelors degree with three years pharmaceutical industry experience with at least two years in trial master file/records management, inspection readiness, clinical operations, and/or related quality/compliance position or HS Diploma with five years pharmaceutical industry experience with at least 2 years in trial master file/records management, inspection readiness, clinical operations, and/or related quality/compliance position.
    • Study start-up and close-out. 
    • Minimum of three (3) years of exposure to multiple domestic and international trials
    • Understanding of ICH/GCP requirements

    Knowledge, Skills and Abilities

    • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
    • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
    • Excellent communication and presentation skills
    • Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

    Supervisory Responsibilities

    No

    Statement

    MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

    Equal Opportunity Employer/Veterans/Disabled

     

    For more information about our commitment to equal employment opportunity, please click here.

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