This is a global R&D level position focusing on supporting the Global Clinical Development Operations (CDO) function as part of the CDO Business Strategy & Operations group, to manage and facilitate the management of clinical trial/clinical project related contracts as per guidance of the legal department and other applicable Company policies and procedures. This includes but is not limited to preparing/reviewing and negotiating standard terms and conditions language and requests for changes to such language by clinical sites in clinical trial agreements and related contracts for all R&D studies worldwide, management of the POA (Power of Attorneys) documents that may be granted to a Service Provider, controlling, and tracking the contract signature process to ensure compliance with the contract approval requirements. The individual will have a paralegal background and experience with review and feedback on requests for changes to company defined standard T&C sections of master or country specific clinical trial agreements. This person should be comfortable in bridging between clinical operations teams, site contracting teams and legal teams. They must be process oriented, strong on process enhancement and control needs, rigorous and organized. We see the Clinical Contract Manager as a key partner in supporting our clinical trial excellence strategy. Main responsibilities / job expectations Responsibilities will include, but are not limited to the following: Clinical Contract Management:
The Clinical Contract Manager works closely with the CDO project teams, R&D Service Providers, clinical sites, and other R&D functional leaders across Clinical Operations, Legal, Finance, Corporate Compliance to ensure appropriate contracts are in place for each of the clinical trials and clinical operations projects and that service providers are engaged to support clinical operations.
Draft, evaluate, negotiate, execute & archive Clinical trial/ Clinical project related contracts (MSA and complex contracts will remain under R&D Legal however, this position will provide support to R&D Legal if requested)
Establish and maintain Service Provider relationships by serving as a single point of contact for contractual matters.
Provide contract-related issue resolution, both internally and externally
Monitor and complete contract close-out, extension, or renewal, as appropriate.
Communicate contract-related information to all stakeholders.
Work closely with R&D Legal in addition to the study leads.
The Clinical Contract Manager is responsible for the overall coordination and management of the contract flow for the study related contracts in such a manner that it is compliant with legal and compliance guidelines, is delivered in the required quality and within the agreed timelines. The Clinical Contract Manager participates in the low-risk resolution of contract-related issues as they arise and escalates to R&D legal any potential high-risk dispute.
Operations:
Must operate under strict compliance with legal guidelines in respect to what changes can be accepted to standard T&C versus what needs to be referred to Legal for opinion. Has a proactive and “common-sense” mindset and helps build, enhance, and train the right process controls to ensure compliance within the R&D functions globally in regards contract management. Specifically:
- In close collaboration with R&D Legal actively contributes to establishing Clinical Contract Management within CDO by: § Fostering the synergies with all the relevant functions (compliance, finance, legal...). § Developing, integrating, and maintaining the relevant tools, processes, and training to support the contract management; and § Maintaining contract templates together with the associated guidelines and training
Fostering team work to ensure a holistic approach across the R&D HUBS (e.g., Cambridge, France, UK) and the clinical functions.
Supporting team or asset integrations from a site/study contract perspective and addressing any relevant training needs
Developing a network of champions within each of the relevant functions to build a strong administrative network of super users (e.g., administrators and CRAs) to harmonize process across the organization regardless of location.
Working closely with project, people, and functional leaders across CDO, Legal, Finance, and Service Providers to ensure appropriate contracts are in place.
General Responsibilities:
Keeps up to date on emerging clinical trial related contractual management trends in the pharmaceutical industry including country specific requirements for T&C that differ to the Company standard T&C and how this impacts the CTAs to be executed within that country.
Develops and implements robust clinical contract management training to R&D personnel as needed, together with associated tools and templates.
Supports the continuous improvement of standard templates and processes for clinical contracts.
Ensures smooth collaboration and regular interactions with all the internal stakeholders including Global Ethics and Compliance and Corporate Legal
Escalates contract related delays / issues to the relevant RDLT member for transparency and issue resolution needs.
EHS Responsibilities: · Complies with applicable EHS regulations and procedures. · Participates in the site's EHS performance by reporting risks, malfunctions, or improvements. · Participates in mandatory EHS training.
Knowledge, abilities & experience Education / Certifications:
Master’s degree required in relevant focused area.
Experience:
5+ years of post-qualification experience, including relevant international experience in clinical trials contract management.
Experienced in reviewing standard terms and conditions and legal approved standard clauses within the company’s contract templates and the variations in such clauses as may be needed to address country specific requirements (Global)
Experienced in negotiating with trial sites’ and service providers’ legal and / or contracting teams across international locations.
Experience working with R&D teams and cross-functional teams.
Demonstrated ability to juggle multiple contract / tasks demands at one time whilst remaining responsive to internal clients’ requests.
Languages:
Fluent in English
Additional languages a plus
