
10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
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10,000+ employees
đĽ Healthcare
đź Consulting
đŚ Logistics
Healthcare ⢠Consulting ⢠Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
⢠Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for industry-sponsored clinical trials ⢠Produce and review site-specific contracts from country clinical trial agreement templates ⢠Submit proposed CTAs and investigator budgets for site review ⢠Negotiate budgets and contracts with sites, Site Contracts Service Centre, SSUL, and sponsors ⢠Perform quality control, arrange CTA execution, archive documents, and capture metadata ⢠Administer contract management processes across protocol, informed consent, institution, investigator, vendor, consultant, and customer agreements ⢠Generate amended contract and budget documents and streamline contract, proposal, and internal processes ⢠Collaborate with Site Contract Service Center and Legal to align site contracts with sponsor master service agreement terms ⢠Work with SSU lead, Clinical Operations, and Finance to validate departmental budget loads and backlog ⢠Identify contract and process risks, provide solutions, and escalate deviations ⢠Support business development and represent site contracts/SSU at internal or customer meetings ⢠Track country/site contracting timelines and milestone progress in the SSU tracking system ⢠Collaborate with legal, finance, and clinical operations teams on legal and budgetary issues ⢠Maintain contract templates, budget templates, site-specific files, and databases ⢠Serve as communication liaison regarding contract statuses and pending issues ⢠Train and mentor less experienced staff and maintain training materials ⢠Facilitate contract execution by company signatories ⢠Monitor project financial aspects and contract hours/tasks, escalating discrepancies ⢠Review and comply with SOPs and WIs and ensure timesheet compliance
⢠BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience ⢠Advanced degree preferred ⢠Moderate contracts management experience, including experience in a contract research organization or pharmaceutical industry ⢠Management experience preferred ⢠Strong knowledge of the clinical development process and legal and contracting parameters ⢠Strong computer skills in Microsoft Office Suite ⢠Customer-focused and able 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 ⢠Strong organizational skills with proven ability to handle multiple projects ⢠Excellent communication, presentation, and interpersonal skills ⢠Quality-driven in all managed activities ⢠Strong negotiating skills ⢠Strong problem-solving skills ⢠Ability to mentor and motivate more junior staff ⢠Ability to provide quality feedback and guidance to peers ⢠Ability to contribute to a training and Quality assurance plan within SSU and update SOPs/WI ⢠Ability to comply with SOPs, WIs, training records, and timesheet requirements
⢠Career development and progression ⢠Supportive and engaged line management ⢠Technical and therapeutic area training ⢠Peer recognition ⢠Total rewards program ⢠Inclusive culture ⢠Reasonable accommodations, when appropriate, for employees or applicants with disabilities
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