Clinical Document Management Specialist

Summary

Join Owkin's Clinical Operations team as a Document Management Specialist and contribute to the development of the company's Trial Master Files (TMFs). You will play a key role in ensuring the quality and completeness of clinical documents across global studies. This position requires robust pharmaceutical industry experience, in-depth knowledge of electronic document management systems, and a strong understanding of data privacy regulations. The ideal candidate will be detail-oriented, possess excellent communication skills, and thrive in a fast-paced environment. Owkin offers a flexible work organization, a friendly work environment, and the opportunity to work with an international team.

Requirements

• Robust pharmaceutical industry (or equivalent) experience
• In depth experience of electronic document management systems (eTMF, eQMS, LMS etc)
• Solid knowledge of Data Privacy Regulations EU, UK & Global including but not limited to requirement for data privacy in clinical trials
• Records management/TMF experience
• Associates/Bachelor’s degree or equivalent preferred
• Sufficient knowledge of regulatory requirements and ICH-GCP guidelines on the conduct of clinical trials to support exemplary records management
• Demonstrated ability to work independently, take initiative, complete tasks to deadlines
• Strong attention to detail, document organization skills, ability to establish priorities, schedule and meet deadlines
• Solid communication skills and strong customer/stakeholder focus with ability to interact in a global, cross functional organization
• Ability to communicate effectively with external vendors, including appropriate issue escalation, and responding to enquiries and concerns
• Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands
• Advanced computer proficiency familiarity with Sharepoint (and Google docs a bonus)

Responsibilities

• Be responsible for high quality clinical document deliverables across global assigned studies in support of DDO ensuring effective lifecycle management of the clinical section of the TMF
• Be key contributor and member of the clinical study team
• Monitor completeness and quality (QC) of the Clinical TMF, including elements outsourced to CRO
• Support the monitoring of training record completion in the LMS
• Ensure effective communication and issue escalation internally and with external vendors
• Oversee consolidation, transmission and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process
• Ensure compilation of CSR appendices in accordance with relevant processes
• Champion inspection readiness through periodic quality assessment of clinical records including but not limited to Sponsor Oversight Folder, internal study correspondence, Training Records
• Ensure clinical records are minuted, filed in a timely manner
• With direction from the COM/CTM prepare clinical records for agency inspection
• Support assigned TMF corrective action plans under direction of Senior CDM/Manager this may be in response to audit, inspection or routine checks
• Champion initiatives to enhance efficiencies in document management practices including development of new written processes as necessary
• Support Managers in training efforts for new personnel
• Act as secondary/back-up administrator for the QMS and LMS
• Perform technical review/QC of documents including but not limited to study documents such as the protocol, SOPs, WIs and agreements relevant to the study

Preferred Qualifications

• Setting up eTMF systems
• Relevant vendor selection or oversight
• Process improvements
• Inspection Management

Benefits

• Flexible work organization
• Friendly and informal working environment
• Opportunity to work with an international team with high technical and scientific backgrounds