
1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
đĽ 0 minutes ago
đ Serbia, Bulgaria â Remote
â° Full Time
đĄ Mid-level
đ Senior
đ Manager
đť Ghost score 16%
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1001 - 5000 employees
Founded 1997
đź Consulting
đĽ Healthcare
đŚ Logistics
Consulting ⢠Healthcare ⢠Logistics
ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.
⢠Oversee negotiation of clinical study agreements on assigned trials ⢠Act as a subject matter expert for sponsors and stakeholders in assigned countries ⢠Plan Clinical Site Agreement execution strategies aligned with study start-up plans and client expectations ⢠Prepare Clinical Site Agreement templates, payment terms, country budgets, fallback positions, and negotiation parameters ⢠Lead study-level CSA negotiations and drive finalization and execution according to timelines ⢠Negotiate directly with clinical sites in assigned countries ⢠Escalate out-of-parameter contractual and budgetary requests to sponsors or internal decision-makers ⢠Advise stakeholders on issue resolution and seek internal support as needed ⢠Create and maintain document status reports and update department tools, systems, and team members ⢠Ensure appropriate documentation is maintained throughout the contracting process ⢠Coordinate status updates with project teams and sponsors ⢠Manage discussions concerning fair market value of investigator budgets and payment terms ⢠Manage study team and sponsor expectations regarding global CSA negotiation progress ⢠Participate in regular study calls ⢠Establish strong sponsor relationships to support smooth negotiations and repeat business ⢠Collaborate with legal, finance, and clinical operations departments on legal and budgetary issues ⢠Be accountable for Site Contracts delivery on assigned projects and initiatives ⢠Act as local subject matter expert in the country of residence or assignment ⢠Perform other duties as required by the Line Manager
⢠BS degree in law, business, life sciences, or a health-related field, or equivalent combination of education and experience ⢠Strong CRO operational experience ⢠Track record of success in Site Contracts Management in a local, regional, international, or global capacity ⢠Thorough knowledge of applicable regulations, drug development, and clinical project management procedures ⢠Understanding of country-specific Site Contracts requirements in one or more countries, at least the candidate's country of residence ⢠Ability to work across geographic regions ⢠Ability to mentor and coach less experienced staff ⢠Good presentation, documentation, and interpersonal skills ⢠Proficiency in MS Office, including Word, Excel, and PowerPoint, Outlook, and Internet ⢠Ability to handle multiple tasks and meet deadlines in a dynamic environment ⢠Attention to detail ⢠Effective oral and written communication skills ⢠Ability to work independently ⢠Strong leadership skills ⢠Strong local contracting experience ⢠Strong English language skills and fluency in local language(s) required ⢠Bulgarian, Czech, Hungarian, and Serbian preferred
⢠Remote work option ⢠Work-life balance ⢠Collaborative, international team environment ⢠Career growth opportunities ⢠Early ownership and professional development through mentoring and coaching ⢠Opportunity to contribute to meaningful work bringing safe and effective pharmaceutical treatments to patients ⢠Supportive culture ⢠Collaboration with experts in clinical research, pharmacovigilance, and quality consulting
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