Clinical Document Management Specialist

About the role:

As a Document Management Specialist you will be adding to the Clinical Operations team within Drug Development team at Owkin.  

Clinical Operations is a new department (less than a year in the making). The team is under the leadership of Diane Chisholm, Head of Clinical Operations, to whom you will report.  Diane likes to foster an attitude of Inspection Readiness at all times in a culture of innovation, creativity and teamwork.  She is passionate about empowering team members and driving meaningful progress towards achieving our goals whilst maintaining compliance with GxP.  

The Document Management Specialist will provide primary support to ensure the overall health of the Trial Master Files (TMFs). Oversee set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors. With support from the management team, performs periodic quality assessments of clinical TMF documents where required.

In particular, you will:

• 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.

About you

Above all, you should be excited by the idea of working at the intersection of drug discovery and machine learning. 

The successful candidate will have a ‘team-first’ kind of attitude; be independent, curious and detail-attentive; thrive in a dynamic, fast-paced environment; and be fun to work with.

In terms of skill set, we are looking for someone with:

• 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)

Preferred qualifications/bonus:

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