DOCS has partnered with a highly prestigious organisation with one of the most robust pipeline within the industry. We have a great job opportunity for a Budget &Contract Negotiators or Regulatory Specialists with experience in site contract negotiations who are ready to work part time on a 6 months contract. The role can be home-based. if you are a freelancer or are interested in a part time fixed term contract, please apply .
Roles & Responsibilities of the position
• Responsible for analyzing contract requests/needs and translating into appropriate contracts/budgets for company sponsored clinical trial agreements.
• Responsible for compiling, negotiating and finalizing clinical trial agreements and site specific (budget)templates with the clinical trial sites, according to protocol specifications, international Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations.
• Responsible for assuring the site and vendor payments are made as listed on the clinical trial agreement and in compliance with appropriate laws and guidelines.
• Acts as primary local/country contact for clinical trial agreements and site specific (budget) templates with clinical trial sites.
• Calculate study budget based on results of negotiations with third parties;
• Create local budget overviews with CTM support;
• Evaluate potential needs for contract amendments and manage amendment lifecycle; ensuring that contract amendments are appropriately executed;
• Actively contributes to budgeting, contracting and payment to third party process improvement;
• Bachelor’s degree or equivalent, in a science or health related field
• At least 2 years Clinical Research experience, experience in site contract negotiations
• Strong knowledge of regulations, legislation and guidelines applicable for the conduct of clinical studies
• Strong interpersonal skills, including capability to engage in professional relationship building an networking
• Be able to verify translations (make good sense in local languages, is clear and readable) and to be able to adapt language readable format for a patient, where applicable
Remuneration & other details
Competitive salary, medical insurance, annual holiday and other benefits.
Please contact Dariusz Sternlicht, Recruitment Consultant at DOCS on +48 606 130 397 or email your up-to-date CV to: firstname.lastname@example.org
DOCS provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.
Regulatory, Start-Up, Budget Negotiation, Contract Specialist, RA, Pharmaceutical, Contract Negotiator, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Contract, Warsaw, Poland