For Current Gilead Employees and Contractors:
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General Position Summary / Purpose:
The Development Business Operations / Contracts Document Senior Associate in the Document Management Team (DMT) will collaborate with Development Business Operations leadership, Clinical Records, Clinical Operations Teams, and Development Business Operations functional groups in the planning, development, and implementation of standards, processes, and projects for DMT designed to ensure the effective and efficient archival of clinical documents and related information created in support of clinical research. Comply with relevant regulatory, legal, country specific and corporate requirements to produce and maintain inspection readiness for clinical records.
- Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical documents
- Collaborate with Development Business Operations leadership, Development Business Operations functional groups, clinical operations teams, and functional areas outside of Development Business Operations to ensure compliance with policies, procedures, and the practices of Gilead’s records management/TMF archival initiative
- Work with management and DMT personnel in the development, implementation and maintenance of classification and filing systems to meet administrative, research, regulatory, legal, and financial requirements (e.g. filing of documents in Gilead legal archive, Apttus, eTMF GDAR system in the current state and in the Veeva system in the future state in 2020)
- Work with management to manage business continuity procedures, including management of electronic and paper documents
- Perform central intake activities including creating records of incoming documents within the first business day of receipt, filing of incoming documents, and retrieve copies of paper protocol-related documents from TMF room for Apttus filing as applicable
- Responsible for ensuring the central intake report is generated daily and published in a timely fashion
- Evaluate regulatory and Gilead business recordkeeping, archiving requirements, and organizational objectives and ensure Development Business Operations DMT is aligned and up-to-date with all
- Responsible for the ongoing maintenance of eTMF (GDAR in the current state and Veeva in the future state in 2020) and Apttus contract filing
- Ensure record filing is kept current and performed accurately by DMT members
- Develop and maintain quality assurance and control plans
- Responsible for monitoring accuracy of the team’s work by providing reports and metrics to management team
- Potential lead of assigned meetings/projects and will mentor and provide guidance and support to more junior staff with projects of varying levels of complexities
- Develop and maintain department process guidance, training materials, policies and procedures, and other reference documents
- Define and manage processes associated with the storing, archiving, indexing, scanning, and classifying clinical records
- Manage the off-site storage of records for documents managed by Development Business Operations and collaborate closely with Gilead Clinical Records team to ensure appropriate process is in place for off-site archival of paper documents
- Collaborate and partner with the Information Technology (IT) GDAR Team, through stellar communication and solid project management. Resolve efficiently any issues encountered by collaborating with IT in the improvement of processes, procedures, and effective use of available information technologies
- Operate as the Subject Matter Expert (SME) in the electronic TMF (eTMF)
- Respond to internal and/or external inquiries related to contract filing and records retention of those documents; supports internal and external audits and inspections, including provision of data on contract filing
- Manage the DMT mailbox by responding to daily email inquiries, review of incoming documents for technical review and 30-day contemporaneous filing in eTMF (GDAR in current state and Veeva in future state in 2020) and Apttus
- Participate in the development, implementation and maintenance of internal systems and processes used to manage collection of documents and the filing and archival of the documents in Apttus, GDAR in the current state and Veeva in the future state in 2020
- Track and maintain departmental metrics related to operational activities, progress of contract filing and archive, quality measurements and other variables. Develops effective tool sets for capturing metrics and generating reports
- Responsible for the daily activities associated with the quality check of clinical documents and management of contract filing and archival
- Ensure completion of appropriate documentation to track archival of files
- Support Development Business Operations Functional Groups and Clinical Operations Study Teams in understanding TMF-related responsibilities, requirements and expectations
- Lead the monthly TMF review process by providing support and guidance to DMT members in the project management, quality control, communication and delivery of the associated reports to management, functional groups and leadership
- Provide management with DMT TMF metrics; completeness and quality of TMF documentation and content, including the percent completeness and risk level analysis of outstanding items on a periodic and/or ad hoc basis as requested by management
Qualifications / Requirements
- 5 plus years of project or clinical trial management experience
- 3 - 5 years in management position responsible for the establishment and maintenance of procedural documents
- 2 plus years of project management experience with PMP preferred
- 3 plus years of Clinical Research Associate (CRA) or relevant records management/ TMF management experience equivalent experience preferred
- Experience in CTMS preferred
- Experience in Salesforce and Veeva platforms preferred
- Exemplary interpersonal skills with proven demonstration
- Knowledge of FDA and other global clinical trial regulations, as well as detailed knowledge of ICH and GCP guidelines related to Clinical Document Management
- Expert level of proficiency in Microsoft applications including, but not limited to, Microsoft Word, Project, PowerPoint, Visio, Access and Excel
- BA/BS required
- The Sr. Associate needs subject matter expertise in Trial Master File (TMF) Quality and Records Management
- The Sr. Associate has foundational skills in being influential, in leadership and demonstrates advanced teamwork skills; must have proficient knowledge in all TMF and contract filing technical competencies, including quality management and change management.
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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.