25 may
|
Syneos Health
|
Buenos Aires
25 may
Syneos Health
Buenos Aires
Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q1c4j
Contract Specialist – Sponsor Dedicated – Buenos Aires Hybrid
Role Summary
Roles within the Site Start-Up / Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements.
The role includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification.
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; 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, capturing metadata; reviews contracts for completeness and accuracy, ensuring corrections are documented.
Administers all contract management processes, coordinating 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, streamlining 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.
Collaborates 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, 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 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, 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 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), ensuring 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
BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
Advanced degree preferred.
Moderate contract management experience that includes experience in a contract research organization or pharmaceutical industry.
Strong knowledge of the clinical development process and legal and contracting parameters.
Customer focused and capable of managing challenging priorities, remaining versátil and adaptable in stressful situations.
Excellent understanding of clinical trial process across phases II-IV and ICH GCP.
Good understanding of 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 problem-solving skills.
Ability to mentor and motivate more junior staff.
Demonstrates an ability to provide quality feedback and guidance to peers.
Contributes to a training and quality assurance plan within SSU and updates SOPs/WI.
Equal Employment Opportunity
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.
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Postúlate en Kit Empleo: kitempleo.com.ar/empleo/q1c4j
📌 Contract Specialist - Sponsor Dedicated - Buenos Aires Hybrid
🏢 Syneos Health
📍 Buenos Aires