Clinical Study Manager

  • Salary: 350 per day Ltd
  • REF Number: 00033508
  • Consultant: Russell Oakley
  • Contact: 01246 457733
  • Date Published: 07.08.2015
  • Closed Date: 17.02.2016
  • Sector:
  • Location: Uxbridge,
  • Discipline:

Russell Oakley at CK Clinical is currently looking for two Clinical Study Managers for a global pharmaceutical company based in West London.

Role 1

  • In house studies, multi-country late phase study management
  • Accountable to ensure all relevant studies follow SOPs and GCP.
  • With direction, matrix with key study conduct partners.
  • Assist with maintaining relationships and monitor performance of CRO's and other vendors.
  • With direction from Senior Clinical Staff, collaborate with Clinical Operations functional groups (Regional Monitoring, Data Management, stats, clinical supplies and Operations Management) to ensure on time delivery of studies.
  • Work closely with the LOC study managers and address any study related questions, address issues related to study drug supply.
  • Manage sites/countries transitioning from study to commercial supplies.
  • Manage study budgets
  • Escalate issues as needed to the Clinical Investigational Lead/medical monitor.
  • Provide input into identifying implications of study progress upon overall timeline goals and conduct plans.
  • With oversight manage study start-up, conduct and close-out.
  • Assist in the management of CRO's or other outsourcing partners as appropriate.• Provide input into content and execution of investigator meetings / may present selected topics.
  • Provide input into development of CRF.
  • Provide input into site selection with coordinated input.
  • Aptitude for clinical systems, can do attitude, ability to work across projects/studies.

Role 2

  • Study Management of 2x late phase studies: Global CRO contract set up & task assignment and oversight through to end of recruitment, additional vendor contracting, management and oversight
  • Assist in the management of CRO's or other outsourcing partners as appropriate
  • Accountable to ensure compliance with SOPs and GCP.
  • With direction, may matrix with key study conduct partners.
  • Assist with maintaining relationships and monitor performance of CRO's and other vendors.
  • With direction from Senior Clinical Staff, collaborate with internal and external functional groups to ensure on time delivery of studies.
  • Work closely with the CRO study/project managers and address any study related questions, address issues related to study drug supply.
  • Support management of study budgets
  • Escalate issues as needed (eg to the medical monitors or clinical leaders).
  • With oversight manage study start-up, conduct and close-out at CRO.
  • Assist in the management of CRO's or other outsourcing partners as appropriate.
  • Provide input into content and execution of investigator meetings / may present selected topics.
  • Provide input into development of CRF.
  • Provide input into site selection with coordinated input.
  • Aptitude for clinical systems, can do attitude, ability to work across projects/studies.

The ideal candidates will have prior study management experience, although all therapy areas will be considered for this role.

For more information or to apply for these CSM positions please contact Russell Oakley on +44 (0)1246 45 77 33 or email roakley@ckclinical.co.uk. 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 CL33508 in all correspondence.

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