Position: Clinical Documentation Manager
Karyopharm Therapeutics is a clinical-stage pharmaceutical company focused on the discovery and development of novel first in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
Responsible for providing TMF leadership to all aspects of the TMF and members of the project team e.g., Clinical Project/Trial Managers, Head of Clinical Operations, Data Manager, Regulatory etc. for all TMF related activities. The Clinical Documentation Manager leads the oversight of all TMF related activities including the management of TMF vendor(s), technology, process all the while liaising with the study teams regarding the continuous review, and process improvement, of the TMF to ensure that the TMFs are inspection ready. The Clinical Documentation Manager performs work within established study protocols and company procedures under minimal supervision.
- Manages and provides oversight guidance to TMF vendor(s)
- Oversees the creation, maintenance and revision of the Karyopharm TMF Content Model
- Key contributor, author and/or decision maker relating to overall TMF policy, standards, procedures, plans and other TMF specific tools. Identifying inconsistencies and inefficiencies in processes and recommended solutions.
- Trains study team members on TMF policies, standards, procedures, tools and TMF related activities
- Responsible for managing and/or mentoring documentation specialists
- Responsible for leading and/or co-leading process and technology initiatives within the TMF group
- Oversee the creation, maintenance, and archival of Trial Master Files/ eTrial Master Files in accordance with Karyopharm Standard Operating Procedure (SOP), GCP, EMA and FDA regulations
- Collaborate with the internal cross-functional project team and vendors to identify and mitigate TMF risks and ensure timely completion of TMF deliverables.
- Identifies trends related to TMF (issues, risks, etc.) across the programs to ensure quality documentation; assists in the development and management of TMF related metrics for companywide reporting.
- Conducts and/or oversees the completion of gap analysis and quality control checks of TMFs in accordance with Karyopharm’s SOPs and operational best practices relating to document management; performs follow up on the findings with the entire project team.
- Conducts / maintains quality control procedures to ensure accurate maintenance of files, including periodic basic quality, inventory and completeness checks to ensure accurate maintenance of files.
- Maintains expert knowledge and ensured compliance with applicable ICH-GCP Guidelines, local regulatory requirements, Karyopharm’s SOP and study-specific procedures.
- Bachelor’s degree or nursing qualification is required. Scientific/health care field
preferred, but not required.
- Minimum of 8 years’ experience in relevant TMF field (e.g. clinical site, CRO, Sponsor or clinical trial vendor).
- Expert working knowledge of the TMF reference model 3.0 and of current regulatory requirements and guidelines governing clinical research and GCP related documents
- Relevant experience in clinical research (clinical operations and/ or QA preferred) or related field.
- Adequate Good Clinical Practice training.
- Expert with technology and ability to learn new systems quickly.
- Strong knowledge of MS Word, Excel, PowerPoint and Outlook.
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
- Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization.
- Must be able to work in a fast-paced environment with demonstrated ability to appropriately prioritize competing tasks and demands.
- Ability to work proactively and independently and be successful within a cross-functional team.
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