Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with minimal oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Identifies project and/or country level and/or individual site contract related problems and works with internal and external team members to provide and implement solutions. Serves as subject matter expert across all Site Contracts functions. Trains and mentors site contracts staff and proactively identifies ways to improve internal project operations. Establishes strong working relationships with customers, internal project teams and sites. May lead internal team education or process improvement initiatives. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
· May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
· Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review.
· Negotiates budget and contract with site and 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.
· Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
· Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
· Works closely with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
· Works closely with SSU lead, Clinical Operations and Finance to validate the load of departmental budgets and corresponding backlog.
· Identifies possible contract or process operational risk and proactively works within the team to provide solutions. Establishes strong working relationships with SSU lead, customer and internal project teams. Escalates deviations to department leadership and/or Site Contract Service Center and/or Legal Department.
· Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
· 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.
· Maintains and actively supports review and development of contract templates, budget templates and site specific files and databases.
· Serves as key 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.
· 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.
· Actively participates in higher level discussions about overall company goals, departmental objectives, and specific project aims.
· Facilitates the execution of contracts by company signatories.
· 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
- Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
- Management experience preferred
- Strong knowledge of the clinical development process and legal and contracting parameters
- Strong computer skills in Microsoft Office Suite
- Customer focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
- Good understanding clinical protocols and associated study specifications
- Excellent understanding of clinical trial start-up processes
- Project management experience in a fast-paced environment
- Good vendor management skills Strong organizational skills.
- Excellent communication, presentation and interpersonal skills
- Quality-driven in all managed activities
- Strong negotiating skills
- Strong problem-solving skills
- Ability to mentor and motivate more junior staff
- Demonstrate an ability to provide quality feedback and guidance to peers
- Contribute to a training and Quality assurance plan within SSU and update SOPs/WI
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.