Clinical Research Manager

New

Skills

Clinical Trial Management CRF Authoring EDC Systems eTMF Management GCP Compliance ICF Authoring Presentation Skills Protocol Development Regulatory Submissions Risk Management

We are seeking a Sr. Clinical Research Manager to lead and manage clinical studies from inception to completion. In this fully remote role, you will collaborate with internal stakeholders to ensure study objectives align with business goals and maintain compliance with regulatory guidelines. Your expertise will help in developing study timelines, budgets, and resource plans, making a significant impact in the pharmaceutical and wellness industry.

Key Responsibilities
  • Develop and manage study timelines, budgets, and resource plans.
  • Coordinate with internal stakeholders to align study objectives with business goals.
  • Proactively identify risks and implement mitigation strategies.
  • Author core clinical study documents, including protocols, ICFs, and CRFs.
  • Lead full study lifecycle execution from startup through closeout.
  • Prepare and manage IRB submissions, amendments, and continuing reviews.
  • Ensure studies are conducted in compliance with GCP and regulatory guidelines.
  • Design and oversee clinical data systems, including EDC and eTMF.
Required Skills & Qualifications
  • Bachelor's degree in related medical field.
  • Minimum of 10 years' clinical research experience in Pharmaceutical or wellness brands.
  • Hands-on experience managing and executing development studies in-house.
  • Direct experience authoring protocols, ICFs, and CRFs.
  • Proven experience managing IRB submissions and approvals independently.
  • Advanced presentation skills and strong knowledge of GCP, ICH guidelines.
  • Experience with clinical data systems (EDC, eTMF) in lean environments.
  • Ability to travel for site visits within California up to 20%.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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