Our challenge. Your impact.
We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.
At the earliest date possible we search for a Monheim, Germany or Slough/UK based
Site Contracts Manager
who can support our global Outsourcing, Contracts and Strategic Partnering team.
The primary goal of this position is to ensure that site contracts for Global studies are of the highest quality at the lowest possible price. The Site Contracts Manager will represent the function by collaborating and supporting the Clinical Project Managers (CPM) or Clinical Research Organization (CRO) to prepare and obtain the best terms and conditions with the selected sites in all clinical trials. The Site Contracts Manager is a single point of contact for the CPM or CRO for clinical site/investigator contract related matters.
- Lead negotiations and management of clinical site/investigator contracts (including fees/budgets) and scope changes to insure a cost-effective, expeditious and successful solution to outsourcing needs. Take the lead on negotiations when necessary and follow up with CRO and pending issues.
- Lead negotiation of documents for clinical studies including, but not limited to:, indemnification letters, power of attorney, confidential disclosure agreements, and informed consents
- Support the study team’s reconciliation of each study closeout for site payments and verify UCB has record of all final site agreements.
- Collaborate with clinical study team to determine the clinical trial specificities to be considered in the clinical site/investigator contract terms and conditions and to identify potential sites / country specificities.
- Collaborate with Head of Site Contact Management, Legal, Insurance, and other departments, as necessary, to customize standard site and investigator contracts and templates for each trial and country.
- Assist in the development of detailed specifications of the project activities, distribute to CRO, and manage the negotiation process with the clinical sites/investigators by supporting the CRO as needed.
- Ensure that all clinical site/investigator contracts appropriately represent the responsibilities of the various parties involved in the clinical study.
- Insure that all UCB SOPs are adhered to and federal regulations and GCP guidelines are followed with respect to OC&SP.
- Interact on daily basis with other OC&SP personnel and other relevant interfaces to ensure integration of activities.
- Ensure that vendor and investigator performance is regularly assessed and shared with Head of Site Contact Management, OC&SP personnel and relevant interfaces during regular debriefings (GSCO, Legal, Vendors, etc.).
- Identify business improvement opportunities and participate and/or lead in creating solutions which improve OC&SP efficiency and effectiveness.
Your qualifications and experience level for this role:
- 8 years of significant experience negotiating legal language and budgets with clinical sites/investigators.
- Experience in the Pharmaceutical or Biotechnology industry (10 years) or experience in CRO industry (10 to 15 years).
- Experience managing and/or working with CROs is a plus.
- Bachelor’s degree is required in any of several concentrations: science, finance, legal, business. Master’s degree in the same concentrations is preferred. A legal and business background is a plus.
- A track record of successful investigator site contract negotiations is a required.
- 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 UCB at meetings.
- Ability to speak, read, and write proficiently in languages other than English is a plus.
- Experience with GrantPlan, Grant Manager, or similar databases are a plus for site budget/grant development
Have we made you curious?
Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7500 people in approximately 40 countries, we generated revenue of EUR 4.5 billion in 2017.
Do you want to find out more about us then visit our website: www.ucb.com