Clinical Research Study Manager
Russell Oakley at CK Clinical is recruiting for a Clinical Research Study Manager to join a company in the pharmaceutical industry at their site based in Uxbridge on a contract basis. The role is with the Investigator Led Studies team and is for 12 months in the first instance.
Job Details: Track receipt of ISS concepts/proposals from Investigator Sponsor Facilitate communication with Sponsor via collaboration with TA/Medical staff (eg: acknowledgement of receipt of proposal, provision of scientific comments on protocol) Complete sponsor qualification process (in collaboration with TA/Medical staff as needed) Facilitate categorization, review and approval of ISS 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 Exec Medical Director/GDL or review committee eg: GPRC, IPRC Support meetings internally (e.g. GDT, product-specific ISS Review meetings, IMT, NAMT, Finance) and with Sponsor as appropriate (creating agendas, minutes, etc) Provide protocol submission package including product specific safety information, details of the company's ISS process and requirements to sponsor for protocol review and start-up activities Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labelling activities, expiry dates/memos as appropriate Partner with GCP&P on budget negotiations and ensure conduct of Fair Market Value assessment Collaborate with GSM 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 Approval Package (ISSAP) documents and forward for signature approval Enter data (e.g.. milestone tracking, enrolment status) and maintain source systems Track essential documentation and archive in TMF 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 external CRO vendors appointed by the sponsor as necessary Assist Global Operations with product reconciliation and destruction as appropriate Co-ordinate review of publications as necessary Support training and co-ordination of local ISS Associates and GCSM staff (regional role only) Manage direct reports and/or act as mentor to develop Associates/Sr. Associates (where relevant, and excluding LOC staff) Review ISS metrics, assist with measurement of compliance to process requirements Communicate ISS status to management as requested Identify and facilitate resolution of ISS cross-functional issues; lead cross-functional task forces or working groups under supervision of Senior Manager
Qualifications: Basic Qualifications BA/BS/BSc or RN. Specialist experience in life sciences or medically related field. Previous biopharmaceutical clinical research experience (clinical research experience obtained working on Investigator Sponsored or academic-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company).
This is an excellent opportunity to join a Global Pharmaceutical company
For more information or to apply for this position, please contact Russell Oakley on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34506 in all correspondence.