
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, Romania â Remote
â° Full Time
đĄ Mid-level
đ Senior
đ Manager
đť Ghost score 15%
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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 in line 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 within planned timelines ⢠Negotiate directly with 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 by staff involved in contracting ⢠Coordinate status updates with project teams and sponsors ⢠Manage discussions regarding 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 of assigned projects and initiatives ⢠Act as local subject matter expert in the country of residency or assignment ⢠Perform other work-related 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 with a 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 specific country requirements pertaining to Site Contracts delivery in one or more countries, at least in own country of residence ⢠Ability to work across geographic regions ⢠Ability to mentor and coach lesser experienced staff and support SSU Management on administrative or departmental activities ⢠Good presentation, documentation, and interpersonal skills ⢠Proficient in MS Office (Word, Excel, PowerPoint), Outlook, and Internet ⢠Ability to handle multiple tasks and meet deadlines while delivering high-quality work in a dynamic environment ⢠Attention to detail and effective oral/written communication skills ⢠Ability to work independently to meet deadlines ⢠Strong leadership skills and ability to teach/mentor lesser experienced team members ⢠Strong local contracting experience ⢠Strong English language skills and fluency in local language(s) required ⢠Bulgarian, Czech, Hungarian, and Serbian languages preferred
⢠Flexible remote work arrangements ⢠Work-life balance ⢠Collaborative, international team environment ⢠Career growth opportunities ⢠Trusted ownership and early impact ⢠Passionate and collaborative team of clinical research, pharmacovigilance, and quality consulting experts
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