Manages the workflow process for paper and electronic document management. Prioritizes work for the Document Control Specialist team. Assists in resourcing to accommodate on-going workflow. Guides and trains junior team members in functional areas of expertise. Leads quality assurance and process improvement efforts, as needed. Performs support tasks related to creating and maintaining the document/file repository and archival for all study related paper documents, electronic documents and other documents requiring document control.
Detailed Description Essential Job Functions
1. Oversees daily workflow and assists with monitoring productivity and quality of department outputs.
2. Works closely with functional team management to ensure deliverables in accordance with relevant SOPs/WIs, customer and regulatory requirements. Escalates quality concerns to functional management and leads remediation efforts where possible.
3. Prioritizes work for the Document Control Specialist team. Assists in resourcing to accommodate on-going workflow
4. Creates and maintains the document repository, scanning, and indexing for all study-related documents. Receives, inventories, routes and maintains applicable project documents (e.g. clinical documents and clinical files as well as project specific regulatory documents, etc.).
5. Insures the security and compliance of all documents related to active and archived projects. Insures that all project documents are maintained in accordance with relevant SOPs/WIs.
6. Responds promptly to each request received for a project document or project file, and insures timely and appropriate delivery, as well as timely and accurate re-filing all project documents and project files. Insures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room.
7. Upon study closure, prepares subject files, prepares inventories, and reconciles files to listings provided by clients/ Project Team Lead; ships files to client and or off-site storage.
8. Controls access to the Document Control Room/Trial Master File Room according to applicable SOPs/WIs. Responsible for maintenance of the physical space in the Document Control work area/Trial Master File work area,, including setting up project file structure for each project and restricting access to project files.
9. Participates in project specific training as required.
10. Mentors and trains junior team members in functional area of expertise.
Job Requirements Requires an AA/AS degree or equivalent related experience. College courses in the scientific/regulatory field plus nominal experience in a clinical and/or medical environment. Demonstrated leadership skills required. Strong knowledge of FDA regulations and guidelines with respect to regulatory documents and familiarity with medical terminology is necessary. Requires good verbal, written, and organizational skills with a team-oriented approach. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Proficiency in Microsoft Office Suite and email is required.
Additional Details At INC Research, It's "All About the Process"
For more than two decades, INC Research has been a therapeutically focused contract research organization with an unrivaled reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric trials. Our Trusted Process™ methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina, and has a presence in 40 locations worldwide.
INC Research is pleased to offer our employees a comprehensive benefits plan that includes: Healthcare Coverage (Medical/Dental/Vision), Flexible Spending Accounts, 401(k), Life Insurance and AD&D, Short- and Long-Term Disability, Supplemental Income Protection, Employee Assistance Program, Paid Time Off and Paid Holidays.
How To Apply Please complete or update your profile using our online career site (iRecruitment) to apply and be considered for this opportunity.
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