Senior Clinical Documentation Manager

DUTIES AND RESPONSIBILITIES:

· Primary contact for service providers to ensure a study-specific TMF (electronic) is in place at study start-up, and complete at study close.
· Establish and review TMF/eTMF specifications to ensure quality and standardization is established and maintained throughout the course of a trial and across company projects.
· Develop, implement and adjust standards where necessary to ensure compliance with industry best practices and enhance efficiencies.
· Establish and coordinate metric reports to ensure progress is current and key deliverables are on track.
· Perform or lead TMF/eTMF audits to assess compliance with agreed standards; determine consistency; identify gaps, and provide recommendations for process improvements.
· Support regulatory submission activities and due diligence efforts as needed.
· Manage contract or support staff if assigned.
· Assume a strategic role in the eTMF vision.
· Develop or support new approaches in document management processes for the tracking and version control of key documents and records.
· Perform job duties independently with minimal guidance from Manager.
· Participate in clinical operations initiatives and programs as assigned.

QUALIFICATIONS AND REQUIREMENTS:

· Minimum 3 years focused primarily on managing TMF/eTMF.
· Effective communication skills; able to write and present clearly and succinctly in a variety of communication settings and styles, can get message across.
· Collaborates effectively with the study team, cross-functional team members, and external partners.
· Able to take action in solving problems while exhibiting judgment and realistic understanding of issues.
· Proficient computer skills in: Microsoft Office Suite, Internet research skills, Database and document management software

EDUCATION AND EXPERIENCE:

· Experience in electronic document control systems.
· At least 5-7 years of experience in pharmaceutical or biotech industry.
· Bachelor's Degree or equivalent knowledge and skills acquired.
· Good working knowledge of GCP and ICH

- 10% travel may be required (face-to-face meetings with service providers)To find out more about Real Staffing please visit www.realstaffing.com