Site Contracts Manager

🔥 0 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 15%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 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.

📋 Description

• Oversee negotiation of clinical study agreements on assigned trials • Act as 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 and country budgets with fallback positions and negotiation parameters • Lead study-level negotiations and drive finalization and execution of Clinical Site Agreements within planned timelines • Negotiate directly with sites in assigned countries • Escalate out-of-parameter contractual and budgetary requests to sponsors or internal decision-makers • Provide consultation on escalated queries and advise stakeholders on issue resolution • 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 regarding fair market value of investigator budgets and payment terms • Manage expectations regarding progress of global Clinical Site Agreement negotiations • Participate in regular study calls • Establish strong working relationships with sponsors 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 country of residency or assignment • Perform other work-related duties as required by the Line Manager

🎯 Requirements

• BS degree in law, business, life sciences, 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 for 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 • Good presentation, documentation and interpersonal skills • Proficiency in MS Office, Outlook and Internet • Ability to handle multiple tasks and meet deadlines while delivering high-quality work in a dynamic environment • Attention to detail • Effective oral and written communication skills • Ability to work independently to meet deadlines • Strong leadership skills • Strong local contracting experience • Strong English language skills and fluency in local language(s) required • Bulgarian, Czech, Hungarian and Serbian languages preferred

🏖️ Benefits

• Remote work option • Work-life balance • Collaborative, international team • Career growth opportunities • Trusted ownership early • Opportunity to make an impact through purposeful work • Passionate and collaborative team of experts • Diverse and inclusive workplace where every voice counts