Company: INC Research
Closing Date: 16 Mar 17
Salary (£): Negotiable
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.
We are currently looking to strengthen our Document Control team in Ukraine and are seeking a Trial Master File Lead (TMF Lead) to join our team in Kiev.
A brief summary of duties:
• Attends Trusted Process meetings such as Kick-Off, Quick Start Camps, Jump Start Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
• Leads the TMF set-up and structure, configures completeness reports and sponsor/project specific completeness reports, and develops the list of expected documents and the gap analysis.
• Collaborates with the Project Lead (PL) and Functional Leads (FL)
• Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME as applicable to the project/program.
• Designs and/or delivers study specific TMF training
• Generates and provides Completeness Reports and inspection readiness metrics to the Project Team.
• Participates in audits/inspections and prepares for audits to ensure audit-readiness for the TMF.
To succeed in this role you will need the following skills/experience:
• BA/BS in the life sciences, business administration, or related discipline; or equivalent combination of education and experience.
• Moderate experience in a Contract Research Organization or related field.
• Experience with leading/co-leading studies from award into maintenance on a Global scale.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
• Ability to perform several tasks simultaneously to meet deadlines.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.
European Head Office
River View, The Meadows Business Park,
|Tel:||+44 (0) 1189 335 300|
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