Senior Site Activation Coordinator - Contracts and Budgets

at  IQVIA

JOIN US IN OUR AMAZING JOURNEY!!

Fantastic opportunity to embed yourself in our global clinical operations team working as Senior Site Activation Specialist, Contract & Budget negotiation in Romania (Legal Background). Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs.

Skills & Requirements:

• We are looking for at least three years of experience professional in Clinical Reseach Organization with Legal background and potential negotiation skills since our position implies a lot of negotiations with doctors and local vendors.
• Bachelor degree in Law
• Fluency in Romanian & English .
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• LOCATION: #Hybrid model (Bucharest

• Preparation and negotiation of contracts, annexes and budgets for conducting a clinical trial.
• Cooperation (good communication skills) with research teams as well as centers and researchers in the field of contract negotiations, legal education would be an advantage.
• Additional attributes: meticulousness, accuracy, regularity..
• Ensures the successful negotiation and on-going management of clinical trial agreements (CTA) with investigative sites and investigators.
• Works cross functionally with Clinical and RSU Team in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines.
• Reviews and negotiates budgets for CTA based on the calculation provided by the Sponsor.
• Communicates and explains legal/ budgetary issues to internal and external parties per project guidelines.
• Prepares and concludes amendments to CTA based on client requested contract changes and based upon study CTA guidelines.
• Appraises contracts for completeness and accuracy and ensures adherence to department guidelines; correct documents and files changes to contracts (QC process).
• Participates in project’s weekly meetings for the purpose of expediting the contract signing process as directed.
• Creates and maintains files for each contract.
• Periodic archiving of contracts for completed projects.

Skills & Requirements:

• We are looking for at least three years of experience professional in Clinical Reseach Organization with Legal background and potential negotiation skills since our position implies a lot of negotiations with doctors and local vendors.
• Bachelor degree in Law
• Fluency in Romanian & English .
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
• Understanding of regulated clinical trial environment and knowledge of drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• LOCATION: #Hybrid model (Bucharest)