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Specialist, Clinical Documentation

Company: FERRING PHARMACEUTICALS INC.
Location: Independence
Posted on: October 12, 2020

Job Description:

Job Title: Specialist, Clinical Documentation Job Description: Contribute to outstanding innovation + Make braver choices Specialist, Clinical Documentation Location: Parsippany As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our people first philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the worlds oldest enemy: disease. Summary: As a member of the clinical operations study team, the Document Specialist will support the TMF Manager/Lead to ensure that the Electronic Trial Master File (eTMF) is audit and inspection ready for both current and past trials. The Document Specialist should serve as a subject matter expert (SME) with the eTMF/TMF, within Development Operations in accordance with relevant regulations, ICH-GCP guidelines and applicable relevant SOPs. The Specialist must maintain the integrity, security, and accessibility of the eTMF/TMF for the entire lifecycle of the study and through storage and archival. Responsibilities: - TMF, eTMF & CTMS Set Up and Tracking - Site Start Up Document creation, distribution and collection - Create and Maintain TMF Plan, TMF Index, TMF Mapping, and SOP List - Perform Document QC per study-specific TMF Plan, issue queries, and obtain query resolution to ensure accuracy and completeness - Study Mailbox set up and management - Perform risk-based quality content reviews and identify/escalate study trends/issues - Coordinate digitization, long-term storage archival, and document maintenance and integrity - Conduct and participate in eTMF/TMF educational workshops and trainings (industry and company specific) - Participate and/or present in departmental and study specific meetings Requirements: - BA or BS degree in Life Science preferred - Minimum 2 years clinical trial experience - Knowledge of GCP / FDA / ICH regulations required - Knowledge of clinical operation processes including study start up procedures, maintenance phase, and study close out procedures - Experience with eTMF - Proficient in MS Excel, Word and PowerPoint. Join our team and youll become part of a close-knit family one in which youll be listened to and your contributions valued. Surrounded by like-minded people, youll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Parsippany

Keywords: FERRING PHARMACEUTICALS INC., Independence , Specialist, Clinical Documentation, Healthcare , Independence, Missouri

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