Senior Site Contracts Specialist - Sponsor Dedicated (Genentech)
Syneos Health/ inVentiv Health Commercial LLC, Raleigh, NC, United States
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, and 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, ensuring 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 streamlines 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
Bachelor's degree in a related field or equivalent experience.
Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
Practical knowledge of a professional area, typically obtained through education combined with experience.
Strong understanding of regulations, SOPs, and project requirements related to site identification.
Excellent negotiation and communication skills.
Ability to manage and review site performance metrics.
Experience in managing site confidentiality agreements (CDAs) and site information forms (SIFs).
Preferred Qualifications
5+ years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment, including ownership of multi-country studies.
Demonstrated expertise negotiating site CTAs and investigator budgets, including direct interaction with sites, sponsors, Site Contract Service Centers, and Legal teams.
Strong experience drafting and managing site-specific CTAs from country or global templates and ensuring alignment with sponsor MSAs and country requirements.
Proven ability to manage contract amendments and protocol-driven changes, maintaining compliance with timelines, quality standards, and documentation requirements.
Experience serving as an escalation point for complex contract, budget, or process issues, with a track record of proactive risk identification and resolution.
Hands‑on experience with SSU tracking systems and contract repositories, including real‑time milestone tracking and metadata management.
Demonstrated leadership in training and mentoring junior staff, including contribution to SOPs, WIs, templates, and internal training materials.
Experience supporting business development activities, such as proposal development, bid defenses, or sponsor-facing meetings.
Salary Range
$56,400 - $95,900
Location
Open to US-Remote candidates.
Certifications
Relevant certifications in clinical research or site management preferred.
Necessary Skills
Strong organizational and time management skills.
Ability to work independently and as part of a team.
Proficiency in using relevant software and tools for site management.
Detail-oriented with strong analytical skills.
Ability to handle multiple tasks and projects simultaneously.
Equal Opportunity Employment
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which Syneos Health operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. Syneos Health 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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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, and 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, ensuring 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 streamlines 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
Bachelor's degree in a related field or equivalent experience.
Moderate contracts management experience that includes experience in a contract research organization or pharmaceutical industry.
Practical knowledge of a professional area, typically obtained through education combined with experience.
Strong understanding of regulations, SOPs, and project requirements related to site identification.
Excellent negotiation and communication skills.
Ability to manage and review site performance metrics.
Experience in managing site confidentiality agreements (CDAs) and site information forms (SIFs).
Preferred Qualifications
5+ years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment, including ownership of multi-country studies.
Demonstrated expertise negotiating site CTAs and investigator budgets, including direct interaction with sites, sponsors, Site Contract Service Centers, and Legal teams.
Strong experience drafting and managing site-specific CTAs from country or global templates and ensuring alignment with sponsor MSAs and country requirements.
Proven ability to manage contract amendments and protocol-driven changes, maintaining compliance with timelines, quality standards, and documentation requirements.
Experience serving as an escalation point for complex contract, budget, or process issues, with a track record of proactive risk identification and resolution.
Hands‑on experience with SSU tracking systems and contract repositories, including real‑time milestone tracking and metadata management.
Demonstrated leadership in training and mentoring junior staff, including contribution to SOPs, WIs, templates, and internal training materials.
Experience supporting business development activities, such as proposal development, bid defenses, or sponsor-facing meetings.
Salary Range
$56,400 - $95,900
Location
Open to US-Remote candidates.
Certifications
Relevant certifications in clinical research or site management preferred.
Necessary Skills
Strong organizational and time management skills.
Ability to work independently and as part of a team.
Proficiency in using relevant software and tools for site management.
Detail-oriented with strong analytical skills.
Ability to handle multiple tasks and projects simultaneously.
Equal Opportunity Employment
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which Syneos Health operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. Syneos Health 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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