Senior Manager, Clinical Outsourcing

  • Salary: Competitive
  • REF Number: 00034619
  • Consultant: Charlene Dutchman
  • Contact: 01246 45 77 33
  • Date Published: 09.12.2015
  • Closed Date: 26.02.2016
  • Sector:
  • Location: Hertfordshire,
  • Discipline:

Charlene Dutchman at CK Clinical is recruiting for a Senior Manager, Clinical Outsourcing to join a leading Pharmaceutical company based in Hertfordshire, to work full time, on a freelance basis, for 12 month in the first instance.

As a Senior Manager, Clinical Outsourcing you will lead and manage activities related to the outsourcing of clinical services, negotiation and maintenance of contracts for CROs and technical suppliers. You will also manage the processes which support the implementation and management of global outsourcing.

Key Accountabilities/Responsibilities will include the following:

  • Supporting the development of outsourcing requirements for phase I-IV global clinical trials including functional services.
  • Leading and supporting the qualification and evaluation process for new service providers.
  • Leading the process of Request for Proposal (RFP) development from vendor selection to final contract execution.
  • Managing contracting activities including preparation of CDAs, MSAs, Service Agreements, Work Orders, Amendments etc.
  • Negotiating services description, budgets, and payment schedules using costing tools as necessary.
  • Facilitating study kick off / familiarization meetings to clarify timelines, scope of work, roles and responsibilities and budgets.
  • Supporting project teams in the resolution of service provider performance issues.
  • Managing and negotiating project scope changes through interactions with internal and external contacts.
  • Facilitating and attending lessoned learned meeting as necessary to incorporate improvements in new projects.
  • Collaborating effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical contracts.
  • Maintaining central databases for contract tracking purposes, workload management, metrics tracking.
  • Contributing to the development and support implementation of new processes for the department and other tasks that may be required to accomplish Clinical Outsourcing goals and objectives.
  • Managing and/or mentoring junior members of staff including the review / QC of work as necessary and acting as subject matter expert for outsourcing.

As a Senior Manager, Clinical Outsourcing, you will have the following qualifications, skills and experience:

  • First degree a minimum. Second degree or CIPS qualification desirable.
  • Significant experience of negotiating and tracking progress of clinical CRO contracts, ensuring compliance with contracts during progress of projects, liaison and consultation with legal department.
  • Direct experience of managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
  • Excellent understanding of CRO cost models and budgets.
  • In depth understanding of the services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO)
  • Must have excellent written and oral communication skills
  • Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others.
  • Flexible and proactive.
  • Excellent analytical and problem solving skills.
  • Eye for detail.
  • Highly organised with strong negotiation skills.
  • Must have good leadership and project management skills .

For more information or to apply for this position, please contact Charlene Dutchman on 01246 45 77 33 or email Alternatively, please click on the link 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 CL34619 in all correspondence.

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