Company: DOCS Global
Location: Cambridge,United Kingdom
Reference: Ref AS-020142
Closing Date: 18 Jan 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS is the Functional Resourcing Division of ICON Plc. This means that when someone joins the DOCS Team rather than working in a CRO environment you will be directly insourced with one of our many pharmaceutical / medical device partners working on their SOPs, IT Systems, Projects and sometimes in their offices. We now have a brand new role exclusive to DOCS for an eTMF Expert to be fully insourced and onsite at a global headquarters in Cambridge.
Roles & Responsibilities of the position
You will oversee the TMF Index as this is the reference model so it’ll require a lot of individual input but as this role reports directly to the Global Director of Document Management you will gain incredible insight to the operations at a global level but also you will be an integral sounding board and expert for the team
Major Duties and Responsibilities:
• Manages the TMF index for use in eTMF system and in paper TMF following documented change control process and ensuring input from each functional area.
• Creates, reviews and implements eTMF processes including detailed work instructions.
• Works with numerous stakeholders at a variety of levels to ensure input.
• Contribute to eTMF archive strategies to ensure effective processes and compliance with records retention.
• Implements record retention policies for clinical documentation in accordance with Corporate, Legal, and other applicable policies and/or regulations.
• Supports eTMF adoption and inspection-readiness activities.
• Functions as subject matter expert on eTMF functionality.
• BA or BS degree (or higher) in a scientific/technical discipline or equivalent local degree/experience
• eTMF experience
• Records and information management experience
• Previous experience with use of or oversight of an eTMF system.
• Proven experience implementing eTMF processes on a global, cross functional scale.
• Experience in preparing for and being part of GCP compliance. audits/assessments/document reviews is required; prior involvement in regulatory inspections is desirable.
• Excellent knowledge of excel or other tools for metrics collection.
• Working knowledge of clinical trial design, execution and clinical operations/development highly desirable.
• Demonstrable knowledge of drug development processes.
• This role requires current working rights in the UK
Along with a competitive base salary DOCS offers a comprehensive range of benefits that includes Health Insurance, Life Assurance, 25 days holiday (rising up to 27 days), childcare vouchers and much more.
To find out more about this role please use the following contact details:
0207 832 2306 / Philip.Jones@docsglobal.com
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