Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with moderate oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as technical expert across all Site Contracts functions. Trains and mentors junior team members and proactively identify ways to improve internal project operations. Establishes strong working relationships with customer, internal project teams and sites.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
May participate in internal team education or process improvement initiatives.
Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site.
Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
Supports in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions.
Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
Collaborates with internal and external legal, finance, and clinical operations departments, including communicating and explaining legal and budgetary issues.
Facilitates the execution of contracts by company signatories.
Maintains contract templates and site specific files and databases.
Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team work products. Maintains and updates training material for site contract team.
Acts as a communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.·
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
QUALIFICATION & REQUIREMENTS
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
Advanced degree preferred.
High level of contracts management experience.
Experience in a contract research organization or pharmaceutical industry essential.
Strong knowledge of the clinical development process and legal and contracting parameters.
Strong computer skills in Microsoft Office Suite.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
: Site Operations