The Site Contracting Manager may be responsible for planning and leading Site Contracting efforts for small, simple North American only clinical trials or for several countries of a large global trial. The Site Contracting Manager will be responsible for negotiating clinical trial agreements directly with clinical sites participating in Vertex's clinical development programs. This individual will generate the site agreements using legal templates, will work closely with Vertex legal to finalize the terms and conditions of the contracts, will be responsible for the negotiation and finalization of site budgets.
The Site Contracting Manager will be a member of the project teams and work closely with the Legal department, GTAG, and clinical operations. This position will be required to work under tight timelines.
- Provides day-to-day vendor oversight of CRO and ensures that Vertex trial activation standards and processes are implemented
- Shares trial activation information for study planning discussions, identifies trial activation risk and delays and escalates appropriately
- Ensures that data needed for Planning & Knowledge Management is captured and submitted correctly and efficiently
Key accountabilities
- Vendor oversight
- Partners with assigned representative in CRO to ensure that vendor is clear about and able to carry out assigned trial activation responsibilities
- Day-to-day review/monitoring of CRO against timelines, quality and budget to meet Drug Shipment Approval (DSA) and performance metrics
- Spot checks of regulatory documents (e.g. ICFs, Budgets and Contracts); evaluates quality and on-going performance
Project management
- Adherence to internal (Vertex) and external (CRO's own, regulatory) processes and standards
- Alignment, coordination and information sharing with colleagues in CO and other Vertex functions
- Identifies trial activation risk and delays at study level, communicating issue to GTAG and CO colleagues
- Resolves issues as appropriate, brings in other GTAG /Vertex resources as necessary to solve problems
- Planning, Risk Management, Knowledge capture and application
- Involved in SET meetings - especially study planning discussions - to share trial activation best practices and analytics and advise on appropriate actions
- Ensures study information (countries, sites, investigators, timelines) is accurately submitted and captured into Invoke and Knowledge Management
- Interfaces within Vertex/with CRO,Vertex COSL (peers with similar experience level), Other CO,colleagues as needed, SET, Regulatory Affairs, Legal, Finance, CRO, Vertex dedicated representatives
Minimum Qualifications
- Bachelor's degree is required
- Experience in vendor oversight (CRO), including identification, escalation and mitigation of trial activation risk
Preferred Qualifications
- Experience and expertise in managing high-volume clinical study startup activities
- Demonstrates thorough knowledge and understanding of key regulatory authorities and regulatory requirements, ICH Guidelines, and GCP's governing the startup of clinical trials
- Ability to work in matrix, cross-functional team
- As a result of being member of SET, develops comprehensive understanding of different departments and functions within Vertex and interdependencies
- Ability to provide input into clinical protocol development
- Strong verbal, written and presentation skills
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.