Site Contracts Specialist Ii
vor 2 Wochen
Job Title: Site Contracts Specialist IIAt Syneos Health, we are seeking a highly skilled Site Contracts Specialist II to join our team.
As a key member of our Site Start-Up (SSU) department, you will play a critical role in ensuring the successful execution of clinical trials.
Key Responsibilities:Administer all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.Lead multi-country projects, negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.Provide support to SSUL in agreeing on country template contracts and budgets, producing site-specific contracts, and submitting proposed contracts and budgets for site approval.Negotiate budgets and contracts with sites via the Site Contracts Service Centre and SSUL, resolving issues until resolution.Perform quality control and arrange execution of CTAs, archival of documents into repositories, and capture of metadata.Review contracts for completeness and accuracy, ensuring corrections are made and documented.Support business development and represent site contracts/SSU at internal or customer meetings.Work with Contract Managers and team members to actively manage ongoing contract issues, performing follow-up on all outstanding contract issues.Generate amended contract and/or budget documents as necessary, prepare contract management documentation for projects, and streamline contract/proposal or internal processes.Initiate and introduce creative ideas and solutions to improve contract management processes.Work within forecasted country/site contracting timelines, ensuring compliance and tracking milestone progress in the SSU tracking system in real-time.Collaborate with internal and external legal, finance, and clinical operations departments, communicating and explaining legal and budgetary issues.Facilitate the execution of contracts by company signatories.Maintain contract templates and site-specific files and databases.Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensure quality of team work products.Act as a communication liaison between site contracts staff and internal and external customers, providing functional guidance and keeping teams aware of all contract statuses or pending issues.Monitor basic financial aspects of projects and the number of hours/tasks available per contract, escalating discrepancies in a timely fashion.Review and comply with SOPs and Work Instructions (WIs) in a timely manner, keeping training records updated accordingly and ensuring timesheet compliance.Qualifications:BA/BS degree in Business Administration, Public Administration, Public Health, or 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 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 associated study specifications.Excellent understanding of clinical trial start-up processes.Project management experience in a fast-paced environment.Good vendor management skills.Excellent written/oral communication, presentation, documentation, interpersonal skills, and strong team-orientation.Strong organizational skills with proven ability to handle multiple projects and excellent communication.Quality-driven in all managed activities.
Strong negotiating skills.
Strong problem-solving skills.Ability to mentor, lead, and motivate more junior staff.Demonstrate an ability to provide quality feedback and guidance to peers.
Contribute to a training and Quality assurance plan within SSU and update SOPs/WI.At 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.
Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with.
When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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.
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