DOCS Global

Clinical Study Manager Investigator-sponsored studies / Permanent / England

Location
Buckinghamshire
Salary
great benefits package / stable and growing company / Top 10 industry leader
Posted
09 Feb 2021
Closes
11 Mar 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

We are looking for a Clinical Trial Manager with both clinical research industry and investigator-led trials experience. The ideal candidate will demonstrate experience of having worked with Investigators/KOLs on investigator-sponsored study requests. International clinical study management and delivery across multiple countries highly desirable.

 

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
  • 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 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?

    Work with the best! This is a great opportunity to advance your career. To express your interest please send your CV* today to me at 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.

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