Outsourcing & Contract Manager

KEY ACCOUNTABILITIES

• Accountable to manage the content aspects of the clinical trial outsourcing deals– approvals, negotiations, contracting


• Help develop a sourcing strategy which leverages best practice for outsourcing and offshoring and which is aligned to Merck Serono strategy


• Review ongoing outsourcing deals to ensure continuing commerciality


• Conduct regular reviews of vendor performance


• Coordinate with Corporate Procurement on global Master Service Agreements (MSAs)


• Responsible for preparation of sufficiently detailed request for proposal documents in cooperation with the internal customers including an optimal balance between costs, time, and quality considerations


• Responsible for the contract negotiations with service providers including all preceding and subsequent contacts


• Responsible to ascertain the appropriate and timely involvement of legal department , procurement, and other interfaces (i.e. tax, controlling, QA, etc.) during all stages of contract management


• In cooperation with COT, establish and carry out on an ongoing basis analysis of vendor performance to ensure compliance against contracted service levels and continuous improvement.


• Identify and manage potential risks identified within sourcing arrangements, as identified to ensure tracking and resolution by vendors


• Support Clinical Operations Team and Clinical Trial Team to define and document expected service expectations and products to be delivered by vendor
• • Analyze protocol and ensure that the operational needs as well as the strategic intent are covered and addressed in a contract with the CRO to make sure goals are met
  
  
  • Instruct a contract that meets the need of a trial


• Support Clinical Operations Team and Clinical Trial Team  to manage vendor relationships on a day-to-day basis to ensure high-quality service delivery and to address/escalate issues as appropriate


• Provide input to establish criteria for evaluating vendors, support the selection process and drive implementation of these criteria


• Understanding of CRO business model


• Understanding of COT and program needs vs. CRO offerings

STRATEGIC IMPACT

• Responsible for managing outsourcing of clinical research related tasks to external service providers on a global basis.


• Preparing contracts worth ~EUR 100 millions or less that provide for the delivery of services at high quality / on time and also has all the necessary protections to minimize risks to Merck Serono

COOPERATION

Internally

• Other GCO functions – support outsourcing requests/needs


• Corporate Procurement – align on negotiations


• Controlling – monitoring of external spend


• Legal Department  - alignment on templates for negotiations


• Other GRED functions, as appropriate


• Other GDM functions as appropriate

Externally

• CRO service providers


• Other vendors as appropriate

EDUCATION

• Degree in Life Sciences (e.g. Biology, Chemistry, Pharmaceuticals) or business degree  or equivalent

Necessary professional experience

• At least five (5) years of experience in drug development in a pharmaceutical industry or CRO


• Procurement expertise (preferably in clinical research or service procurement)


• Sound background of financial/controlling issues


• Clinical Trial Management a plus

Specifies personal skills and competencies required

• Excellent negotiation skills


• Ability to think beyond own function


• Ability to identify risks and problems and identify solutions


• Excellent communication skills


• Good analytical and strategic thinking


• Strong customer focus


• Ability to work in a multi-cultural atmosphere


• Proactive and self-motivating


• Fluency in English (oral and written)


• Position requires both domestic and international travel up to 20% of time