Outsourcing & Contracts Manager (m/f/d)

to negotiate contracts with CROs

For our client, a TOP20 international pharma company, we are searching as soon as possible for a dedicated and highly motivated

Outsourcing & Contracts Manager (m/f/d)

to negotiate contracts with CROs

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Großraum Düsseldorf

  • Art der Anstellung:

    interim

  • Kennziffer:

    25782

  • Aktualisierung:

    2020-02-04

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Your tasks

The primary purpose of this position is to ensure that the Development and Medical Practice (DevMed) and Patient Value Units (PVU) utilize quality vendors, and that contracts are of the highest quality at the best possible price.

 

For both O&C Manager categories, the main accountabilities include:

  • Lead negotiation of documents including, but not limited to
    • work orders and change orders
    • agreements and amendments
    • consultant agreements
    • confidentiality agreements
  • Support and drive the outsourcing process
  • Lead negotiations of vendor contracts and amendments to ensure a cost-effective, expeditious and successful solution to outsourcing needs
  • Support the clinical study teams and DevMed stakeholders to identify and find solutions to issues with vendors which impede the successful outcome of the provision of services
  • Prospectively identify issues from a budget, timeline and quality perspective and prioritize rectification
  • Ensure that all SOPs are adhered to and federal regulations and GCP guidelines are followed with respect to O&C
  • Interact on daily basis with O&C personnel and other relevant interfaces to ensure integration of activities
  • Ensure that vendor performance is regularly assessed and shared with O&C personnel and relevant interfaces during regular debriefings (GCSO, Legal, GCD, GED, CQA, Vendors, etc.)
  • Identify business improvement opportunities and participate and/or lead in creating solutions which improve O&C efficiency and effectiveness
  • Contribute to the development of a global library of standard contract templates in collaboration with Legal
  • Travel requiring overnight stays, possibly global, is required

 

O&C Managers responsible for clinical study outsourcing have the following additional accountabilities:

  • Represent the O&C function at clinical study team and clinical sub-team team meetings when needed
  • Meet informally with relevant clinical study team members on a weekly basis at study start-up and periodically during the conduct of clinical studies to assure that vendors are providing services as negotiated
  • Oversee a minimum of 10 studies for which the whole study is outsourced.  Lead clinical study team interactions with vendors
  • Support the clinical study team with the generation of cost estimates for incorporation into the clinical study/program budgets, and with subsequent budget planning and forecasting for specific assigned studies
  • Serve as assigned functional lead and first point of escalation for UCB’s strategic partners and preferred suppliers
  • Participate in the development and management of a vendor management program ensuring a collaborative, transparent relationship

Your qualifications

  • Bachelor’s degree is required in any of several concentrations: science, finance, legal, business. Master’s degree in the same concentrations is preferred. A scientific and business background is a plus
  • At least 2 years of relevant experience in the Pharmaceutical, biotechnology or CRO industry. Experience with other professional services companies is an advantage. Experience managing and/or working with CROs is a plus
  • A track record of successful vendor negotiations is a plus
  • Good leadership skills, networking skills, and communication skills
  • Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent the client at meetings. In all regions, fluency in multiple languages is a plus
  • O&C Manager for clinical study activities must additionally have direct or indirect knowledge and experience of clinical trial conduct
  • Team leadership and strong people management skills
  • Ability to work effectively in a global environment
  • Ability to deliver mentoring and training to peers and other groups
  • Good negotiation, facilitation, and conflict management skills
  • Proficiency in the Microsoft office suite
  • Excellent time management and organizational skills
  • Ability to forecast budget projections
  • General knowledge of clinical development including, but not limited to:
    • FDA/EMEA and other relevant regulations and guidance
    • ICH/GCP and regulatory environment
    • Development processes and roles/responsibilities

Your contact person

Jan Büscher
Geschäftsführer

Address

Optares ICM GmbH & Co. KG
Jan Büscher
Heiligengeist Höfe 8
26121 Oldenburg