Clinical Project Manager

1 week ago

Solna, Sweden TFS HealthScience Full time

TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced highly motivated Project Manager focusing on clinical studies across the Nordic and Baltic countries.This position issponsored based.

As a Project Manager a you will play a critical role in the successful execution of clinical studies. You will be responsible for overseeing all aspects of project management ensuring compliance with local regulations protocols and timelines. This position offers a unique opportunity to contribute to cuttingedge research and make a meaningful impact on patient care.

Key Responsibilities:

  • Conduct country prospection and feasibility assessments for investigational centers.
  • Coordinate the setup and progress of clinical studies in accordance with regulations and protocols.
  • Supervise and collaborate with Clinical Trial Assistants (CTA) Clinical Research Associates (CRA) and other study staff.
  • Participate in the review of study documentation and coordinate financial aspects of the study.
  • Coordinate translation and validation of study documents as required.
  • Manage authorization files for submission to Competent Authorities and Ethics Committees.
  • Prepare and perform study management visits and ensure adherence to quality standards.
  • Respond to audit findings and implement corrective actions.
  • Organize investigator training and national investigators meetings.
  • Participate in trainings and pharmacovigilance activities.

Qualifications:

  • Bachelors degree in life sciences or related field; advanced degree preferred.
  • Experience in project management within the pharmaceutical or biotechnology industry.
  • Strong understanding of Good Clinical Practices (GCP) and regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a fastpaced and collaborative environment.
  • Flexibility to travel as needed within the Nordic and Baltic countries.

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