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Site Contracts Specialist, Clinical Trials Experience
Location
Argentina
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Site Contracts Specialist, Clinical Trials Experience
Syneos Health
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. • May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. • Provides support to SSUL to agree on country template contract and budget. • Produces site-specific contracts from country template. • Provide support in submissions for proposed contract and budget for site. • Provides support in negotiating budget and contract with site 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. • Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings. • Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues. • Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions. • 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. • Facilitates the execution of contracts by company signatories. • Maintains contract templates and site specific files and databases. • 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. • Acts as a 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. • 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.
Job Requirements
- BA/BS degree in Business Administration, Public Administration, Public Health, 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 to remain flexible and adaptable in stressful situations.
- Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
- Good understanding 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 as well as strong team-orientation.
- Strong organizational skills with proven ability to handle multiple projects 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.
Benefits
- 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with.
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• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. • May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. • Provides support to SSUL to agree on country template contract and budget. • Produces site-specific contracts from country template. • Provide support in submissions for proposed contract and budget for site. • Provides support in negotiating budget and contract with site 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.
• Receives and analyzes Requests for Proposals (RFPs) documentation including study protocol or synopsis and ensures all appropriate Subject Matter Experts (SMEs) are assigned and notified of the RFP. • Facilitates the development of basic proposal preparation including the coordination of all key strategic and operational areas, preparation and review of proposal and budgets, while ensuring adherence to the Decisions Right policy. • Prepares and modifies strategic proposal and budgets as appropriate to respond to RFPs and revisions, with assistance, based on SME feedback and proposal management staff. • Manages the RFP process from receipt to delivery, including identifying potential RFP barriers and/or their risks for completion while identifying and implementing effective and efficient mitigation strategies. • Obtains third party quotes as needed. • Ensures proposal and budgets align with RFP, client specifications and communications, and internal assumptions. • Creates, and finalizes budgets and contracts in accordance with departmental SOPs/guidance/work instructions. • Attend all relevant meetings and builds relationships with internal and external stakeholders. Proactively leads and facilitates client meetings as required to negotiate costs and terms by targeted client signature date.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level • May lead (with supervision) multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials • Provides support to SSUL to agree on country template contract and budget • Produces site-specific contracts from country template • Provide support in submissions for proposed contract and budget for site • Provides support in negotiating budget and contract with site 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 • Provides supports to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings • Work with Contract Managers and team members with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues • Support in generating amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; and initiates and introduces creative ideas and solutions • 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 • Facilitates the execution of contracts by company signatories • Maintains contract templates and site specific files and databases • 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 • Acts as a 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 • 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
• Works directly with chain of command to develop and implement contracting strategy with various types of providers/facilities across the Health Plan service area. • Evaluates and negotiates physician, ancillary and hospital contracts, including contract language and reimbursement methodologies for fee for service arrangements. • Prepares standard accurate agreements to formalize such arrangements. • Ability to identify data needed to evaluate and develop network reimbursement proposals to develop arrangements advantageous to our members and Health Plan. • Calls upon team analysts for support. • Works directly with team analysts and other department managers to understand how the negotiated agreement is translated into the company's systems. • Prepares timely and accurate communications to other departments for loading finalized agreements into production. • Assists with internal audit of provider records to ensure accurate reimbursement. • Serve as liaison to other departments on contract and reimbursement interpretation issues and ensures timely turnaround. • Must have strong knowledge of the Health Plan's end-to-end provider engagement processes, including interdepartmental handoffs as well as plan policies and procedures to ensure the best possible provider experience. • Manage or participate in project work as assigned. • May be called upon to assist in network education, onboarding and overall network relationship building.


