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Clinical Project Manager

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Princeton, United States Collabera Full time

The Clinical Project Manager will play a pivotal role in managing and facilitating APOC's Clinical Study Program. This individual will work closely with cross-functional teams including Regulatory Affairs, Program Management, Research & Development, and Quality Assurance, as well as external clinical contractors. The Clinical Project Manager will oversee all operational aspects of clinical trials, ensuring compliance with standard operating procedures (SOPs), good clinical practice (GCP), and country-specific regulations. The role will also involve traveling as necessary to facilitate the program.


Key Responsibilities:

  • Clinical Trial Operations: Oversee and resolve operational aspects of clinical trials in collaboration with project teams, ensuring adherence to SOPs, GCP, and country regulations.
  • Documentation Management: Lead the development of clinical documents, including clinical plans, protocols, forms, and reports.
  • Clinical Study Preparation: Manage the preparation and execution of clinical study activities, from initiation to close-out.
  • Monitoring and Reporting: Track and report the progress of clinical studies, providing updates and follow-ups with team members and line managers to resolve any issues that arise.
  • Issue Resolution: Collaborate with cross-functional teams to address and resolve challenges encountered during clinical studies.
  • Process Consistency: Ensure consistency across clinical trials by standardizing study processes and methodologies.
  • Travel Requirements: Travel as needed to assist in the facilitation of the clinical study program.


Qualifications:

  • Experience: A minimum of 5 years of experience in clinical project management, with a focus on IVD devices and regulatory research.
  • Regulatory Submissions: Proven experience managing clinical studies related to regulatory submissions, particularly for US regulatory submissions.
  • BioMedical Expertise: Prior experience working in a BioMed-based company is preferred.
  • Technical Skills: Proficient in developing protocols, managing clinical studies, overseeing data analysis and data cleaning activities.
  • Project Management: Familiarity with project management methodologies is required. Knowledge of statistics and experience with the APOC i-STAT system or equivalent is advantageous.
  • Communication Skills: Strong verbal and written communication skills, with the ability to prioritize tasks and work independently.


Preferred Experience:

  • Hands-on experience with IVD Devices and regulatory research.
  • Background in clinical studies for regulatory submissions in the medical device or biotechnology industries.
  • Experience working in cross-functional teams in a clinical or regulatory environment.
  • Familiarity with data management, data cleaning, and clinical backend activities.