Contract Specialist

Job Overview:

• May act as CL for one-single country studies. May coach, mentor or on-board more junior Specialists

Job Duties and Responsibilities: Sponsor, to agree on country template contract, including review of translated documents as applicable.

• Builds relationships with sites and investigators within country of expertise
• Responsible for distribution, collection and review of site contract and budget documents either directly or through coordination with assigned CRAs and/or Country Experts (CE) 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 CL and, when acting as CL Sponsor, until resolution of issues.
• Ensures quality of documents and arranges execution of CTAs as well as archival of documents into relevant Company systems.
• Responsible for review and negotiation of site study budget
• Perform timely and accurate data entry of site contract and budget statuses in applicable tracking system(s)
• Works in collaboration with the CL to ensure to communicate negotiation statuses to the Project Team and, when acting as CL Sponsor
• Reviews contracts for completeness , translates contracts/edits of the site contracts (as native speaker or sufficiently skilled in the local language(s) to translate/review translations) and accuracy and ensures that corrections are made and documented.
• In collaboration with the CL, forecasts country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon Company 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 on-board new hires or junior Specialists
• Contributes into 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 related field or equivalent combination of education and experience
• Experience
• 4 years of CRO or pharma setting in project related activities.
• Mininum 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 contract and budget practices preferred
• Strong skills in Microsoft Office Suite, email, and voicemail
• 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 Minor lifting,