Site Contracts Specialist

3 miesięcy temu

Warsaw, Polska Ergomed Pełny etat
Job Description

Due to the continued growth of our Global Study Start Up Group, we are now seeking a GERMAN SPEAKING  (Senior) Site Contracts Specialist who will be responsible for managing the site contracting process locally or across a region in support of assigned projects by drafting, negotiating, finalizing and execution clinical site agreements, ancillary agreements or amendments during study startup or maintenance

The (Senior) Site Contracts Specialist will be responsible for (but not limited to) the following activities:

  • Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level
  • Tracks in a timely manner progress of Site contracting activities during Study Start Up or Maintenance and provides clear rational for delays, as well as a contingency plan to mitigate their impact, and escalates any issues as soon as identified.
  • Collaborates with the Site Contracts Lead, project management, clinical management, and clinical operations personnel to achieve project goals. 
  • Acts as country or regional subject matter expert for all such CSA elements on assigned studies for internal and sponsor stakeholders alike and ensures country intelligence is up to date in country intelligence repositories.
  • Create and maintain document status reports’ and update department tools/systems and team members on a regular basis;
  • Ensure appropriate documentation is maintained by Ergomed staff assigned to the contracting process.
  • Contribute to site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
  • Participate in regular study calls to facilitate communication as needed.
  • Establish strong working relationships and collaboration with Sponsor to ensure smooth negotiations and repeat business with Ergomed.
  • Collaborate with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
  • Be accountable for Site Contracts delivery of assigned projects/countries 
  • Perform other work-related duties as assigned.  

 

Qualifications

The ideal candidate will have:

  • Undergraduate or graduate degree in business, law, or life sciences or equivalent combination of education and experience

  • Experience in negotiating CSAs and Investigator grants (preferably above 2 years)

  • Good knowledge of applicable regulations, drug development and clinical project management procedures.

  • Good understanding of specific country requirements pertaining to Site Contracts delivery in Poland and Germany (mandatory) and preferably other countries

  • Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

  • Ability to exercise sound judgement and to make decisions independently

  • Proficiency in using web applications and MS Office (Word, Excel, PowerPoint, and Outlook)

  • Attention to detail, effective oral/written communication skills and good interpersonal skills.

  • Excellent English both speaking and writing.

  • Fluent in Polish and German language

 

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

  • Training and career development opportunities internally  
  • Strong emphasis on personal and professional growth 
  • Friendly, supportive working environment 
  • Opportunity to work with colleagues based all over the world, with English as the company language. 

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