Records Management Specialist(m/w/x)

# Records Management Specialist **CHE | Dulliken | Obere Ey 4** | **Full time** Primary Responsibilities Clinical Records Specialist will collaborate with other Clinical Records staff, to ensure Trial Master File (TMF) and clinical archiving business needs are addressed in a proactive and timely manner ● Acts as primary contact for delivery on archived document requests, such as for submissions, audit-inspections, divestitures • Box Chain of Custody from Business • Searching and retrievals for all Box Requests • Receipt of Clinical Research Organization (“CRO”) transfer forms/boxes for clinical trials • Data entry and proofing of transfer/retrieval form data • Training Business on Electronic Records Management System (“ERMS”) transfer/retrieval processes • Business orphaned record remediation • Development of the procedures and management for record center operations • Serve as central point of contact for Buyer accounts with Supplier • Manage day-to-day activities (security changes, billing, training, etc.) related to all Buyer accounts with Supplier lead with administration of company records retention schedules • Liaison with Supplier account manager • Receiving and tracking of shipments coming from CRO (Clinical Research Organizations) • Preparing the paper documents for long-term Archiving (removing staples, plastic envelopes etc). Packaging & Coding • Creating Database Entries • Scan operator task • Scanning documents (mostly E-TMF wet ink documents) and maintenance of the local archive ● Provide input into functional SOPs, guidelines and system user guides as related to the accuracy and completeness of TMF ● if needed support during inspections in regards to TMF (remotely) ● Contribute to trainings elaboration related to TMF processes (e.g. TMF SOP, eTMF system guides) ● Work on acquisitions in collaboration with the Clinical Records Lead as well as with our CRO partners on our clinical archiving Core Competencies, Skills (e.g. technical, leadership or business competencies, skills, attributes) • Interpersonal Skills/Teamwork – Influences individuals or groups at various levels who may have different interests or goals to reach consensus and achieve team objectives. • Innovative and Creative Thinking - Seeks improvements in work processes, while using judgment to balance creativity with compliance and the requirement to meet timelines. • Analytical Skills/Problem Solving - Gathers and integrates data with the ability to recognize inconsistencies and recommend solutions • Customer Focus - Anticipates and meets immediate and long-term needs of customers, follows through on commitments and communicates realistic goals. • Job Knowledge - Thorough knowledge of TMF processing, and all (e) TMF systems and processes, long term archiving • Commitment to Quality – Consistently produces high quality, follows procedures and meets aggressive timelines • General – independency in thinking, Sense of organization and responsibility, Rigor and respect for the rules Category: Operations Group