The Clinical Document Manager will be responsible for the management of clinical study documents from study start through to final archival, ensuring compliance with company SOPs and process. An important part of this role is ensuring clinical sites are ready for participation as soon as the clinical trial begins and ensuring that a trial master file roadmap is set up at the start of the trial. A focus on inspection readiness is critical.
- Assists with site feasibility including preparation, distribution, collation of responses, and documentation of the decisions related to site selection
- Forecasts anticipated submission/approval timelines and works with investigational sites and study teams to ensure adherence.
- Independent preparation, review, collection, and approval of site level critical documents required for study start up (greenlight for site initiation/release of investigational product) within agreed timelines and in accordance with ICH, GCP, and all applicable regulations, laws and other guidelines.
- Review of informed consent forms used by the investigational sites including negotiating language between central institutional review boards (IRBs) and ethics committees with support from study team and legal department as appropriate
- Serves as direct contact with investigational sites to assist with review and collection of site start up documents
- Perform timely and accurate data entry of the status of document collection and review in the appropriate Clinical Trial Management System
- Work with study team to establish Clinical Trial Master File (TMF) strategy and oversight plan
- Support implementation of eTMF
- Monitors completeness and quality of the TMF (start up to archival), including elements outsourced to CRO and provides status updates to study teams
- Oversees consolidation and archive preparation of the clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout process
- Responsible for leading and managing Clinical Document Specialists
- Ensures effective communication and issue escalation to study team
- Ensures continuous improvement of processes and quality of documents
- Attend study team meetings as required, mandatory for kick off meetings
- Bachelor Degree in related field;
- Minimum 5 years of experience in the pharmaceutical industry related to management of clinical documents
- Familiarity with ICH/GCP and overall understanding of regulatory guidelines
- Strong communication skills
- Flexibility to assume a workload which frequently necessitates an adjustment of priorities.
- Goal oriented self-starter with ability to proactively identify issues;
- Demonstrated ability to work on complex, multi-faceted projects with tight timelines
- Motivated to work in a fast-paced, challenging environment.
- Firm understanding and sense of the importance of paying attention to detail.