Dernière mise à jour : 6 février 2025
Location: India-Asia Pacific - IND-Client-Based
Job ID: 24005604
Description
Syneos Health® est une organisation de pointe en matière de solutions biopharmaceutiques entièrement intégrées, conçues pour accélérer la réussite des clients. Nous traduisons des perspectives cliniques, d’affaires médicales et commerciales uniques en résultats qui répondent aux réalités du marché actuel.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. 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
Job Summary
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.
Job Responsibilities
· 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
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
Discover what our 29,000 employees already know: work here matters everywhere. Nous travaillons dur et intelligemment, tout cela dans le but de fournir des traitements indispensables à ceux qui en ont le plus besoin. Une carrière chez Syneos Health signifie que votre travail quotidien améliore la vie de patients du monde entier. Le fait de nous choisir comme employeur assure une carrière dans laquelle vous serez certains de :