Contracts Specialist Ii

3 months ago

London, United Kingdom Caidya Full time

**Job Title**: Contracts Specialist II**Job Location**: London - UK (Home-based position any UK location considered)**Job Overview**:
The Contracts Specialist II (CS) works in collaboration with project teams and the Contracts Manager to perform key study start-up tasks related to site contracts in their country, or countries, of expertise. These tasks may include country-specific contract template development, site contracts and budget negotiations with participating study sites, review of document translations, and other study start-up activities, as needed for delivery of Clinical Contracts assignments and work obligations. The Contracts Specialist is responsible for the negotiation, execution, and proper filing and tracking of study site contracts within their country or countries of expertise. May coach, mentor, or onboard more junior Specialists

**Job Duties and Responsibilities**:

- Provides country-level expertise and supports the Project Team and Sponsor to agree on country template contract, including review of translated documents as applicable.
- Builds relationships with sites and investigators within the country of expertise
- Responsible for distribution, collection, and review of site contracts and budget documents either directly or through coordination with assigned CRAs in specific countries. May be assigned to sites with complex internal processes or requiring empowerment to independent decision making
- Negotiates contracts with sites and works with the Contracts Manager and Sponsor until resolution of issues.
- Ensures quality of documents and arranges execution of CTAs as well as archival of documents into relevant Caidya systems.
- Responsible for review and negotiation of site study budget
- Perform timely and accurate data entry of site contracts and budget statuses in applicable tracking system(s)
- Works in collaboration with the Contracts Manager to ensure to communicate negotiation statuses to the Project Team and Sponsor
- Reviews contracts for completeness and accuracy and ensures that corrections are made and documented.
- In collaboration with the Contracts Manager, forecasts country/site contracting timelines, ensures they are complied with, and tracks milestone progress in the agreed-upon Caidya tracking system in real-time.
- Facilitates the execution of contracts by company signatories.
- Supports in maintaining contract templates and site-specific files and databases.
- Ensure all relevant documents are submitted to the TMF as per requirements.
- May be assigned to coach, mentor or onboard new hires or junior Specialists
- Contributes to functional improvement initiatives
- Other duties as assigned by the Associate Director of Clinical Contracts, or designee per project-specific requirements

**Supervisory Responsibilities**:
No supervisory responsibilities.

**Job Requirements**:

- Education
- BA/BS degree in a related field or equivalent combination of education and experience
- Experience
- 4 years of CRO or pharma setting in project-related activities.
- Min 1 year of contracts-related experience in a CRO or pharma setting in project-related activities
- Advanced understanding of local health authority requirements related to country-specific site contracts and budget practices preferred
- Skills/Competencies
- Strong organizational, documentation, and interpersonal skills
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
- Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively
- Strong time management and organizational skills
- Fluent in English and local country language
- Capabilities
- Possibility of travel

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