Clinical Trial Manager / Investigator-sponsored research / UK

Investigator-sponsored studies (ISS) Clinical Trial Manager

Home-based  permanent position

We are looking for Clinical Trial Managers having both clinical research industry and investigator-led trials experience. The ideal candidates will demonstrate experience of having worked with Investigators/KOLs on investigator-sponsored study requests with CRO or pharma companies.

Responsibilities

• 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 scientific comments on protocol for ISS or communication with requesting EA physician regarding next steps following request approval)
• Complete sponsor qualification 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 CDA/Confidential 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 specific 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
• Track essential documentation and archive in source system
• Procure updates from the Sponsor regarding enrolment, milestone payments, etc., per contract and initiate and track invoices and payments per contract
• Ensure the provision of safety updates to Sponsor in collaboration with Safety
• Liaise with extremal vendors appointed by the sponsor as necessary
• Assist Global Operations with product reconciliation and destruction as appropriate
• Co-ordinate internal review of publications as necessary
• Support training and co-ordination of local affiliate staff as required
• Act as mentor as required
• Review metrics, assist with measurement of compliance to process requirements
• Communicate investigator-initiated studies status to management as requested
• Identify and escalate issues, and facilitate resolution of non-sponsor cross-functional issues
• Lead or participate in cross-functional task forces or working groups, or process improvement initiatives under supervision of Senior Manager or Director

What is required

• BA / BS/ BSc in the sciences or RN
  • 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
• Vendor oversight (CROs, central labs, imaging vendors, etc.)
• Strong investigator-sponsored study experience gained within the industry at a clinical trial 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

What is offered

• Permanent contract of employment with DOCS seconded to the client
• Full-time
• Fully home-based
• 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

  Why Join DOCS?

  This is a great opportunity to develop further your career with one of the most sought-after pharma industry leader. Embrace a new challenge and apply now for more details. Please contact Elisabeth.Knighton@docsglobal.com

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