Description
Senior Site Contracts Specialist
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
- 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.
Qualifications
What we’re looking for
- 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 with proven ability to handle multiple projects
- 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
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
Additional Information:
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.
Primary Location: Europe – UKR-Kiev-Bazhana-Prospekt
Other Locations: Europe – UKR-Home-Based
Job: Site Operations
Schedule: Full-time
Travel: No
Employee Status: Regular
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