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

Recruiter
DOCS Global
Location
Bedfordshire
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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 RequirementsWhat 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 eligibilityRemuneration & 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

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