Senior Associate, Investigator-initiated studies (UK)

Recruiter
Docs International UK Limited
Location
Marlow
Posted
10 Feb 2018
Closes
15 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Senior Associate to work on Investigator-initiated studies - Office-based in Bucks (Marlow) or Hampshire near Southampton

- Do you have experience of working on either investigator-initiated studies, non-commercial clinical trials or academic/charity-based clinical studies?
- Do you also have work experience gained at either CRO, pharma or biotech?
-

If you do, I want to hear from you! Our client is looking for a candidate to join their well-established team working on investigator-led trial requests.

Responsibilities and key activities include but are not limited to

- Track receipt of investigator-led/non-client sponsored concepts / proposals and EA requests and facilitate / administer ISS 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 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 to develop other Associates / Sr. Associates as required
- Review metrics, assist with measurement of compliance to process requirements
- Communicate status to management as requested
- Identify and escalate issues, and facilitate resolution of investigator-initiated/non-client sponsor cross-functional issues
- Lead or participate in cross-functional task forces or working groups, or process improvement initiatives under supervision of management.

What is required

- Excellent IT skills and ability to work fast and accurately across complex systems
- Valid and current UK working eligibility
- Willingness to attend client' office during in-boarding and to attend ad-hoc meeting once per week on average in their North West Greater London office

Preferred qualifications

- BA / BS/ BSc in the sciences or RN
- Broad experience in life sciences or medically related field, including general biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company

Knowledge

- Ability to understand technical, scientific and medical information
- Understanding of drug development process
- Familiar with concepts of clinical research
- Advanced computer skills
- Experience in interactions with outside vendors, e.g., CROs and contract labs
- Experience with administration of site budgets and grants with supervision
- Experience with development of prospective site-selection criteria
- Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Ability to write and present clearly using scientific and clinical issues terminology
- Experience dealing with time demands, incomplete information or unexpected events
- Good organizational and planning skills
- Experience working effectively in a team / matrix environment

What is offered

- Permanent contract of employment with DOCS seconded to the client
- Full-time
- Office-based either in Marlow (Bucks) or Eastleigh (Hampshire).
- Salary will depend on actual level of experience and skills
- UK benefits to include 23 days annual leave, pension, healthcare cover, etc.Why Join DOCS?
-
- *Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
- 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 ********************************* or ring +33 964 25 67 65.
-

Similar jobs

Similar jobs