Senior Outsourcing Manager
Clinical Outsourcing Manager
Clinical Outsourcing Manager Contract, Pharma, Hertfordshire
Duration: 12 months
Salary: Very competitive, please contact me directly for this
If you are looking for a change so you can work in a fun and friendly environment for a leading FMCG organisation, why not apply for this role today?
He/she will lead and manage with minimal supervision activities related to the outsourcing of clinical services including negotiation and maintenance of contracts for Clinical Research Organisations (CROs) and function service providers for the Oncology Business Group (OBG).
- Support Oncology Business Group (OBG) in the development of outsourcing requirements for Phase I-IV global clinical trials including functional services
- Lead and support the qualification and evaluation process for new service providers
- Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution
- Manage the contracting activities including preparation, finalization, and administration of CDAs,
- MSAs, Service Agreements, Work Orders, Change Orders, and Amendments
- Negotiate services descriptions, budgets and payment schedules using costing tools as necessary
- Facilitate study kick off/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets
- Support project teams in the resolution of study specific service provider performance issues
- Facilitate or attend lessoned learned meetings as necessary to incorporate improvements in new projects
- Manage assigned service provider relationships ensuring successful start-up and efficient outcomes, as applicable
- Monitor outsourcing environment to keep current on providers and industry trends
- Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
- Maintain central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary
- Identify areas for improvement and lead implementation of new department processes and other tasks that may be required to accomplish departmental goals and objectives.
- Mentor junior members of staff in outsourcing or other functions providing guidance on key processes. Regular QC contract documents as necessary
- Act as subject matter expert or category lead for specified service areas
- Degree level or equivalent, second degree or CIPS qualification desirable
- Experience of negotiating and tracking progress of clinical CRO contracts
- Direct experience of managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function
- 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)
- Thorough knowledge of GCP/ICH Guideline and Regulations
- Clear understanding of the drug development process
- Strong understanding of financial and compliance standards
- Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others
- Proficiency in MS Office Suite
Not ready to apply or have some questions first? No problem, please feel free to contact me, Juber Rahman at any time on ******************** / *************************************
If this role is not suited to your skillset, please feel free to share these details within your professional networks as we do offer a generous bonus referral scheme of 250 in vouchers should we go on to successfully please someone you recommend to us.
This job was originally posted as www.emedcareers.com/job/960732721