Clinical Outsourcing & Contracts Manager - London
Charlene Dutchman at CK Clinical is recruiting for a Clinical Outsourcing and Contracts Manager to join a leading Global Pharmaceutical company, on a full time, permanent basis or contract basis, based at their office in London.
As a Clinical Outsourcing and Contracts Manager you will be responsible for coordinating and managing daily outsourcing activities through the evaluation and selection of service providers (SP) (e.g. CROs) in liaison with the study teams, negotiation of Service Provider budgets and contracts, and management of ongoing Service Provider relationships for drug development activities conducted.
Key Accountabilities/Responsibilities of a Clinical Outsourcing and Contracts Manager will include the following:
- Leading teams through the planning, review, analysis and SP selection process including the distribution of RFPs and managing the bid defence process.
- Reviewing and comparing SP proposals, Work Orders and Change Orders for accuracy, completeness and suitability of costing.
- Preparation of SP approval documents in collaboration with the study teams for submission to the Outsourcing Committee at global company HQ.
- Coordinating with the Contracts Manager at the company's global HQ and all relevant staff to prepare and finalise Master Service Agreements (MSAs), Work Orders, Change Orders and Investigator Agreements with SPs.
- Acting as the point of contact with SPs for all contract related tasks.
- Analysing the clinical study protocol and ensuring the services required are adequately captured in the contract with the SP to make sure goals are met.
- Designing payment schedules in order to ensure that payments are made to SPs, according to milestones or work performed.
- Proposing and negotiating (payment) penalties to ensure timelines and/or services are met and that the SP takes responsibility for delivering key targets such as timelines and patient/subject recruitment.
- Drafting and negotiating all company confidentiality, service and consultancy agreements.
- Demonstrating an understanding of legal concepts and principles as they relate to Confidentiality, Service, Investigator and Consulting Agreements.
- Ascertaining the appropriate and timely involvement of Legal Counsel at all stages of contract management.
- Supporting the company functional teams and HQ when appropriate to define and document expected service expectations and products to be delivered by the SP.
- Liaising with SPs to ensure best performance and business relationships. Escalating management issues with the SP as appropriate.
- Implementing tools to best support and improve outsourcing management and vendor practices.
- Collaborating with Legal Counsel and company functional groups in order to develop improvements to document templates and standard processes and tools.
- Providing financial oversight of SPs/studies to include review of payments and invoices where applicable.
- Conducting oneself at all times in accordance with company Quality Management System, working practices and Good Clinical Practice/Good Manufacturing Practice regulations, and ensuring training in these areas is kept up-to-date at all times.
As a Clinical Outsourcing and Contracts Manager, you will have the following qualifications, skills and experience:
- Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals) or business degree or equivalent with clinical trials experience.
- Proven experience of outsourcing experience in pharmaceutical and/or CRO industry.
- Procurement expertise in clinical research.
- Demonstrating effective influencing, negotiating, interpersonal, leadership and team player skills.
- Understanding of contracting principles and applicable regulations governing clinical research.
- Ability to manage own time and to use internal and external resources to meet business needs.
- Customer focused and solution orientated. Ability to implement strategies to ensure success in meeting delivery of objectives with appropriate time, quality and cost results.
- Excellent analytical and financial skills.
- Strong computer skills.
- Good communication skills to include superior written, oral and presentation skills.
For more information or to apply for this Clinical Outsourcing and Contracts Manager position please contact Charlene Dutchman on 01246 45 77 33 or email email@example.com. 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 CL33650 in all correspondence.