Study Start-Up Manager

il y a 3 semaines


Paris, Île-de-France Parexel Temps plein

About the Role:

Parexel is seeking a highly skilled Study Start-Up Manager to join our team in France. As a key member of our single sponsor dedicated team, you will be responsible for managing and conducting start-up activities in compliance with client procedures, documents, local and international guidelines such as ICH-GCP and relevant regulations.

Key Responsibilities:

  • Contribute to the feasibility assessment of potential studies and participate in Local Study Team (LST) meetings.
  • Provide regular updates to Line Managers on study and planned study milestones/key issues during the start-up period.
  • Support Study Management and Monitoring (SMM) in different initiatives and may support site selection process by identifying and assessing potential sites/investigators.
  • Ensure timely collection/uploading of essential documents into the eTMF and support Quality Control (QC) checks.
  • Accountable for study start-up and regulatory maintenance, including submission of proper application/documents to Regulatory Authorities and/or IEC/IRB.

Requirements:

  • 2 years' experience in a similar position in either CRO or Pharma.
  • Good collaboration, interpersonal, verbal and written communication skills.
  • Excellent attention to detail and negotiation skills.
  • Proficient in written and spoken English language required. Fluency in French is essential.
  • Analytical and problem-solving skills, with ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials.

Education:

  • Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification.

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