Clinical Site Contracts Manager
An opportunity has opened for a Clinical Site Contracts Manager to join a well-respected, global Biopharmaceutical company in the UK in a home-based role. You will be joining the company at an exciting time of growth due to the success of their pipeline/ product launches over the last 5 years - perfect for an individual who is looking to grow organically within a progressive company.
Lead negotiation of documents for clinical studies including, but not limited to: clinical site agreements and budgets, indemnification letters, power of attorney, confidential disclosure agreements, and other site related documents, agreements and/or statements.
- 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 Legal, IP Legal, and other departments, as necessary, to customize standard site and investigator contracts for each trial and country.
- Collaborate with the clinical study teams, Compliance, etc. to include acceptaable fees/budget for clinical site/investigator services for studies and programs.
- Develop 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.
- Support 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.
- Ensure that all clinical site/investigator contracts appropriately represent the responsibilities of the various parties involved in the clinical study.
- Support the Head of Site Contract Management in strategic and 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
- Ensure that all SOPs are adhered to and federal regulations and current GCP guidelines are followed with respect to SCP.
- Interact on daily basis with SCP personnel and other relevant interfaces to ensure integration of activities.
- Ensure that investigator performance is regularly assessed and shared with SCP 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 SCP efficiency and effectiveness.
- Contribute to the development of a global library of standard contract templates in collaboration with legal
- Significant experience negotiating legal language and budgets with clinical sites/investigators based on sponsor fallback and not a facilitator but part of the decision (risk based experience necessary). Seeking persons proficient with site agreement finalization for UK, Australia, APAC, and Western Europe.
- Must have experience in the Pharmaceutical and Biotechnology and experience managing and/or working with CROs is a must.
- 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 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 company at meetings.
- Ability to speak, read, and write proficiently in languages other than English is a plus.
- Experience with Microsoft Teams, Excel, Word (working in tracked changes/redlining etc.), GrantPlan, Grants Manager, or similar databases are a plus for site budget/grant development.
- Legal or paralegal background, detail-oriented.
- Ability to read Clinical Study Protocol and understanding its Schedule of Assessments
- Team leadership and strong people management skills (verbal and written)
- Ability to work effectively in a global environment, taking into account different cultures and laws.
- Ability to work effectively in a team environment.
- Ability to deliver mentoring and training to peers and other groups
- Excellent verbal and written communication in English
- Good negotiation, facilitation, and conflict management skills
- Proficiency in the Microsoft office suite (including Teams)
- Excellent time management and organizational skills
- Ability to forecast budget projections, and excellent Excel skills
- General knowledge of clinical development including, but not limited to:
- FDA/EMA and other relevant regulations and guidance
- Current ICH/GCP and regulatory environment
- Development processes and roles/responsibilities
- Ability to identify, assess and implement best practices throughout the function.
Problem solving (Describe the level of "self-starting" thinking required in the for recognizing, analysing and solving problems)
- 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 analyse, evaluate and resolve complex issues and team dynamics
- Ability to build efficiencies and improve processes and procedures
- Exercises independent judgment (risk assessment)
- Ability to achieve consensus in a group through complex and thorough deliberations
- Supports Clinical Development Programs with efficient and effective resolutions
- Ability to work under tight timelines without sacrificing quality
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.