Syneos Health, Inc.
Overview
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, striving to simplify and streamline our work. We collaborate across Functional Service Provider partnerships or Full-Service environments to help customers achieve their goals and accelerate the delivery of therapies. Work here matters everywhere. We are a global team of 29,000 employees across 110 countries, dedicated to changing lives. Location:
ROU-Client Job ID:
25102041 Job Title (summary):
Sr Site Contracts Specialist Responsibilities
May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Produce site-specific contracts from country CTA templates; review and own site-specific contracts from country templates; submit proposed CTA and investigator budget for site review. Negotiate budgets and contracts with sites via Site Contracts Service Centre and SSU with Sponsor until resolution of issues. Perform quality control and arrange execution of CTAs; archive documents into repositories and capture metadata; review contracts for completeness and accuracy and document corrections. Administer all contract management processes at the project level, coordinating with protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents. Generate amended contract and/or budget documents as necessary and streamline internal processes; contribute ideas and solutions. Harmonize site contracts with sponsor’s master service agreement terms in collaboration with Site Contract Service Center and Legal. Validate departmental budgets and backlog with SSU lead, Clinical Operations, and Finance. Identify operational risks and provide solutions; escalate deviations to department leadership or Legal. Support business development and represent Site Contracts/SSU at internal or customer meetings. Track contracting timelines in real time and ensure compliance with SSU tracking systems. Collaborate with internal and external legal, finance, and clinical operations to communicate and explain legal and budgetary issues. Maintain and support review and development of contract and budget templates and site-specific files/databases. Serve as a communication liaison between site contracts staff and internal/external customers; provide guidance and keep teams informed of contract statuses. Train and mentor staff on SOPs; maintain training materials for the site contract team. Participate in higher level discussions about company goals and project aims; facilitate contract execution by company signatories. Monitor basic financial aspects of projects and hours per contract; escalate discrepancies promptly. Adhere to SOPs and WIs; keep training records updated and ensure timesheet compliance. Qualifications
BA/BS degree in Business Administration, Public Administration, Public Health, or related field; advanced degree preferred. Moderate contracts management experience in a contract research organization or pharmaceutical industry; management experience preferred. Strong knowledge of the clinical development process and contracting parameters; good vendor management and Microsoft Office skills. Customer-focused with ability to manage priorities in stressful situations; strong communication, presentation, and interpersonal skills. Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP; understanding of clinical protocols and start-up processes. Project management experience in a fast-paced environment; ability to handle multiple projects; strong problem-solving skills. Ability to mentor and motivate junior staff; provide quality feedback and guidance; contribute to training and QA plans within SSU and update SOPs/WIs. 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. We are committed to a diverse, inclusive and authentic workplace. Additional Information Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks as required. This description is intended to comply with applicable laws and is not an offer of employment. Syneos Health is an Equal Opportunity Employer. If accommodation is needed during the application process, please contact jobs@syneoshealth.com.
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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, striving to simplify and streamline our work. We collaborate across Functional Service Provider partnerships or Full-Service environments to help customers achieve their goals and accelerate the delivery of therapies. Work here matters everywhere. We are a global team of 29,000 employees across 110 countries, dedicated to changing lives. Location:
ROU-Client Job ID:
25102041 Job Title (summary):
Sr Site Contracts Specialist Responsibilities
May lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Produce site-specific contracts from country CTA templates; review and own site-specific contracts from country templates; submit proposed CTA and investigator budget for site review. Negotiate budgets and contracts with sites via Site Contracts Service Centre and SSU with Sponsor until resolution of issues. Perform quality control and arrange execution of CTAs; archive documents into repositories and capture metadata; review contracts for completeness and accuracy and document corrections. Administer all contract management processes at the project level, coordinating with protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents. Generate amended contract and/or budget documents as necessary and streamline internal processes; contribute ideas and solutions. Harmonize site contracts with sponsor’s master service agreement terms in collaboration with Site Contract Service Center and Legal. Validate departmental budgets and backlog with SSU lead, Clinical Operations, and Finance. Identify operational risks and provide solutions; escalate deviations to department leadership or Legal. Support business development and represent Site Contracts/SSU at internal or customer meetings. Track contracting timelines in real time and ensure compliance with SSU tracking systems. Collaborate with internal and external legal, finance, and clinical operations to communicate and explain legal and budgetary issues. Maintain and support review and development of contract and budget templates and site-specific files/databases. Serve as a communication liaison between site contracts staff and internal/external customers; provide guidance and keep teams informed of contract statuses. Train and mentor staff on SOPs; maintain training materials for the site contract team. Participate in higher level discussions about company goals and project aims; facilitate contract execution by company signatories. Monitor basic financial aspects of projects and hours per contract; escalate discrepancies promptly. Adhere to SOPs and WIs; keep training records updated and ensure timesheet compliance. Qualifications
BA/BS degree in Business Administration, Public Administration, Public Health, or related field; advanced degree preferred. Moderate contracts management experience in a contract research organization or pharmaceutical industry; management experience preferred. Strong knowledge of the clinical development process and contracting parameters; good vendor management and Microsoft Office skills. Customer-focused with ability to manage priorities in stressful situations; strong communication, presentation, and interpersonal skills. Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP; understanding of clinical protocols and start-up processes. Project management experience in a fast-paced environment; ability to handle multiple projects; strong problem-solving skills. Ability to mentor and motivate junior staff; provide quality feedback and guidance; contribute to training and QA plans within SSU and update SOPs/WIs. 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. We are committed to a diverse, inclusive and authentic workplace. Additional Information Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks as required. This description is intended to comply with applicable laws and is not an offer of employment. Syneos Health is an Equal Opportunity Employer. If accommodation is needed during the application process, please contact jobs@syneoshealth.com.
#J-18808-Ljbffr