Clinical & Regulatory Affairs Specialist

Industry: Lifescience Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Clinical Affairs

Location: Minneapolis

Workplace: Office-based / availability to travel

Note: Applications not matching basic requirements will not be considered

The ideal candidate has Regulatory and Clinical Operations experience in the pharmaceutical, medical devices and/or Biotechnologies industries. The role will be responsible for the management and direction of the Clinical Affairs department for the conduct of trials across Europe and US. He/She will ensure study conduct in compliance with applicable ISO standards, GCP and SOPs, providing expert advice in the best pathways to achieve study approval in Europe and US. He/She will work in close collaboration with the Project Lead and will be accountable for achieving successful deliverables from the clinical team to the Sponsors factoring regulatory requirements, timelines, scope of work and respecting budgets.

Responsibilities

• Proactively manage project-level operations, including but not limited to, aspects including management of trial timeline, budget, resources with consideration of quality standards and risk mitigation
• Provide efficient and effective updates on trial progress to the Medical Director as requested
• Lead sponsor study start-up processes, including but not limited to, conduct of the trial kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements (CTAs) and budgets.
• Ensure effective project plans are in place and operational for each trial. Proactively coordinate with the Clinical Trial Team to establish the priorities in accordance with applicable project plans, company standard operational procedures (SOPs), GCP guidelines and regulatory requirements.
• Attend study update meetings, ensure meeting minutes are completed, distributed to team members and filed in the TMF in a timely manner. Review and approve site visit reports, ensure tracking, follow-up and resolution of site-specific issues have been completed in a timely manner.
• Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
  
  
  

Qualifications

• Education: Bachelor’s degree in Life Sciences, Master in health-related field is a plus
• Languages: proficiency in oral and written English (additional language considered a plus).
• Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155
  
  
  

Personal Skills

• Ability to communicate, problem solve and work effectively in an international team
• Innovative and self-motivated
• Excellent organization skills and ability to prioritize goals and responsibilities
• Ability to negotiate and communicate with clients professionally
• Proficient computer skills with the ability to understand and assess technology alternatives and implications for current processes
• Ability to be productive and successful in a dynamic work environment