DOCS Global

Clinical Trial Manager / Investigator-sponsored research / UK

5 days left

Location
Homeworking
Salary
great perks and package - great team and good career scope
Posted
09 Feb 2021
Closes
11 Mar 2021
Ref
ISS_mgr
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

Apply for Clinical Trial Manager / Investigator-sponsored research / UK

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs