US Tech Solutions · 1 day ago
Clinical Contract Manager (Global Clinical Development Operations)
Cambridge, MA
Contract
Hybrid
Senior Level
$55/hr - $65/hr
5+ years expUS Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. They are seeking a Clinical Contract Manager to support the Global Clinical Development Operations function by managing and facilitating clinical trial-related contracts, ensuring compliance with legal and company policies.
Information Technology
Hiring Manager
Shivangi Shivpuri
Responsibilities
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
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
Qualification
Required
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
Master's degree in relevant focused area
Company
US Tech Solutions
US Tech Solutions counted among the largest yet the fastest growing staffing firm; all achieved organically.
1001-5000 employees
H1B Sponsorship
US Tech Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2023 (13)
2022 (24)
2021 (18)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Manoj Agarwal
Chief Executive Officer
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