Site Contracts Specialist II - Homebased or Hybrid Working

Overview

Site Contracts Specialist II – Homebased or Hybrid Working

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient in everything we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture where you can authentically be yourself, uniting us globally and guiding how we take care of our people.
• We believe in diversity of thoughts, backgrounds, cultures, and perspectives to create a place where everyone belongs.

Responsibilities

• Administers all contract management processes, including coordination with protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provides 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 corrections are appropriately made and documented.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Works with Contract Managers and team members on active project management of ongoing contract issues; follows 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; 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 real time in the SSU tracking system.
• 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 on departmental 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 teams aware of 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 SOPs and WIs in a timely manner, keeps training records updated and ensures timesheet compliance.

Qualifications

• 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.
• 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 of clinical protocols and study specifications.
• Excellent understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Excellent written and oral communication, presentation, documentation, interpersonal skills as well as strong team orientation.
• Strong organizational skills with proven ability to handle multiple projects and communicate effectively.
• Quality-driven in all managed activities. Strong negotiating and problem-solving skills.
• Ability to mentor, lead and motivate more junior staff.
• Demonstrate ability to provide quality feedback and guidance to peers; contribute to training and quality assurance plans within SSU and update SOPs/WIs.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion and with no prior notice. The Company will determine what constitutes equivalent qualifications. This description does not create a contract of employment. The Company is committed to compliance with applicable laws and accommodations where appropriate under the Americans with Disabilities Act.