I. THE ORGANISATION
UCB – Inspired by patients. Driven by science. At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talents makes the most of who they are, unlocking innovation and setting new standards for patients.
Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?”
And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.
II. THE POSITION
The primary goal of this position is to ensure that site contracts for Med/Dev Global studies are of the highest quality at the lowest possible price. The Site Contracts Manager will represent the OC&SP 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. The Site Contracts Manager will receive the support from Head of Site Contracts Management, Legal, Insurance and other groups, where needed; provide instructions to the CRO resource; and support them in their negotiation with the clinical sites/investigators. As the representative for OC&SP, the Site Contracts Manager will ensure that study timelines are met by collaboratively working with the clinical study team to assist in the management of the CRO and the investigators selected for the clinical studies. In addition, the Site Contracts Manager may support investigator costs for future studies for incorporation into the clinical study/program budgets.
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.
Support and assist the Head of Site Contract Management in operational questions and issues related to site contract management.
Track and ensure execution of all clinical site/investigator contracts, as well as distribution and filing.
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.
Contribute to the development of a global library of standard contract templates in collaboration with Legal.
Travel requiring overnight stays, possibly global, may be required.
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 reguired.
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
Legal or paralegal background, detail-oriented.
Team leadership and strong people management skills
Ability to work effectively in a global environment, taking into account different cultures and laws.
Ability to work effectively in a team environment.
Excellent verbal and written communication in English
Good negotiation, facilitation, and conflict management skills
Proficiency in the Microsoft office suite
Excellent time management and organizational skills
General knowledge of clinical development including, but not limited to:
FDA/EMA and other relevant regulations and guidance
ICH/GCP and regulatory environment
Development processes and roles/responsibilities
Ability to identify, assess and implement best practices throughout the function.
Excellent problem solving skills
Proactive and flexible approach, drive and follow through
Independently manage multiple concurrent responsibilities in a global environment of changing priorities, without close supervision
Ability to analyze, evaluate and resolve issues and team dynamics
Ability to build efficiencies and improve processes and procedures
Exercises independent judgment
Ability to achieve consensus in a group through complex and thorough deliberations
Supports GCSO Programs with efficient and effective resolutions
Ability to work under tight timelines without sacrificing quality
Pharmaceuticals Biotechnology Hospital & Health Care
Research Management Other
Tagged as: Site Contracts Manager
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