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Job Details

Investigator-sponsored studies clinical trial manager - Home-based or Office-based (UK)

Company: DOCS Global
Location: Marlow,United Kingdom
Reference: Ref AS-023675
Closing Date: 25 Mar 18
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

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. *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.

Requirements:

Roles & Responsibilities of the position

• Track receipt of investigator-initiated concepts / proposals and early access (EA) requests and facilitate / administer ISS (investigator-sponsored studies) 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/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
• Track essential documentation and archive in source system, etc.

Job Requirements

What is required
• BA / BS/ BSc in the sciences or RN
o Strong clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company and working experience obtained working on industry-sponsored or industry-partnered clinical trials within the clinical research industry and academic institutions
• Experience in oversight of outside vendors (CROs, central labs, imaging vendors, etc.)
• Strong investigator-sponsored study experience gained within the industry at a clinical trial Lead/Lead CRA or Manager level.
• Influential and effective communication skills
• Excellent IT skills and ability to work fast and accurately across complex systems
• Valid and current UK working eligibility

Remuneration & other details

• Permanent contract of employment with DOCS seconded to the client
• Office-based in the UK either in Marlow (near Maidenhead) or in Eastleigh (Hampshire)
• Fully home-based also available for the right candidate
• Salary will depend on actual level of experience and skills
• UK benefits to include 25 days annual leave, car allowance, pension, healthcare cover, etc.
• Full-time position

Apply for this job: Investigator-sponsored studies clinical trial manager - Home-based or Office-based (UK)

Contact Information:

Address:  DOCS UK
2 Globeside, Globeside Business park Marlow
SL7 1HZ
England
Reasons to work for Docs International
Tel:  +44 (0) 2380 688500
Fax:  +44 (0) 2380 688501
Website:  Visit Our Web Site

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