Clinical Senior Budget & Contract Analyst

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Job description

About this role:

The Sr. Budget and Contract Analyst supports the Global Clinical Operations Center of Excellence, conducting activities consistent with the mission of Global Clinical Operations to inform, connect and advance the company’s Global Clinical Organization. Through coordination with Trial Activation Managers, the Budget and Contract Coordinator conducts clinical trial site start-up activities related to the preparation and approval of clinical study agreements (CSA) and clinical site budgets in collaboration with BSC Legal and Payment group. The Analyst completes these activities ensuring they are carried out consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.  

Your responsibilities will include:

  • Work independently and proactively to coordinate all necessary contract and budget activities during study start-up
  • Manage large portfolio of contract and budget related activities across several studies and division portfolios
  • Coordinate with leadership and clinical study teams to continually prioritize contract and budget reviews as new information and/or considerations are introduced to keep pace with the overall service level targets  
  • Provide updates to the leadership on site start up activities, investigator readiness, regulatory submission and approval status, etc.
  • Develop and foster clinical research site relationships to become a subject matter expert in the contracting and budget finalization process for select clinical research sites
  • Maintain and stay current with divisional clinical study team priorities as applicable to active contracting and budget finalization timelines 
  • Ability to facilitate CSA and budget negotiations with clinical research site
  • Engage management and clinical study teams consistent with escalation pathways, including the identification of risks that may impact achievement of service level agreements and/or study goals
  • Develop, prepare, complete and track required contracting, budget and legal documentation
  • Update and maintain study-specific startup trackers as it relates to contracting and budget details
  • Update and maintain contracting and budget information in Clinical Trial Management Systems
  • File and maintain contracting and budget documentation in eTrial Mater File
  • Escalate risks and/or initiate outreach to leadership, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate
  • Ensure compliance with appropriate regulatory (ICH/GCP, CA, EC, etc.) and internal SOPs/WI, policies & procedures

 

Profile

Education, Qualifications and Experience:

  • Bachelor’s Degree, or an equivalent combination of experience and education
  • 4+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US
  • Experience working with clinical research centers
  • Experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTrial Master Files
  • Experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment
  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment
  • Must be comfortable interacting with clinical research site personnel via phone, email, and in person

 

 

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