Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-020405
Closing Date: 30 Mar 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
Why Join DOCS? Work with the best! This is a great opportunity to further develop your career. To express your interest please send your CV today to find out more details to Elisabeth.Knighton@docsglobal.com or ring +33 964 25 67 65.
Roles & Responsibilities of the position
Responsibilities and key activities include but are not limited to
• Track receipt of investigator-led/non-client sponsored concepts / proposals and EA requests and facilitate / administer ISS or EA process as central point of contact
• Facilitate communication with Sponsor via collaboration with TA/Medical staff (e.g.: acknowledgement of receipt of proposal, provision of scienti?c comments on protocol for ISS or communication with requesting EA physician regarding next steps following request approval)
• Complete sponsor quali?cation process (in collaboration with TA /Medical staff as needed)
• Facilitate categorization, review and approval of proposals with medical personnel (including documentation)
• Initiate and ensure execution of Con?dential Disclosure Agreement where necessary
• Facilitate team review process sign off for proposals, protocols and amendments and submit for review by Regional Medical TA Head, GDL or review committee
• Support meetings internally and with Sponsor as appropriate (creating agendas, minutes, etc.)
• Provide protocol submission package (or open case package for EA) including product speci?c safety information, details of ISS (or EA) process and requirements to sponsor for protocol review and start-up activities
• Partner with Global / Regional Operations representative regarding drug forecasting including clinical trial labeling activities, expiry dates / memos as appropriate
• Partner with Global Clinical Pricing on budget negotiations and ensure conduct of Fair Market Value assessment
• Collaborate cross functionally to notify Sponsor of any actions or information required from Due Diligence process
• Initiate and support the contract execution process in collaboration with legal
• Support the collection of ISS Initiation Package documents (or regulatory documentation for EA) and forward for approval
• Enter data (e.g. milestone tracking, enrolment status) and maintain source systems, etc.
• Excellent IT skills and ability to work fast and accurately across complex systems
• Valid and current UK working eligibility
• BA / BS/ BSc in the sciences or RN
• Broad experience in life sciences or medically related ?eld, including general biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
• Ability to understand technical, scienti?c and medical information
• Understanding of drug development process
• Familiar with concepts of clinical research
• Advanced computer skills
• Experience in interactions with outside vendors, e.g., CROs and contract labs
• Experience with administration of site budgets and grants with supervision
• Experience with development of prospective site-selection criteria
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scienti?c and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience working effectively in a team / matrix environment
What is offered
• Permanent contract of employment
• Office-based in the UK, either in Marlow (near Maidenhead) or in Hampshire (Eastleigh).
• Salary will depend on actual level of experience and skills
• UK benefits to include 23 days annual leave, pension, healthcare cover, etc.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
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