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Precision Medicine Group

Biomarker-driven clinical development services and consulting

Clinical Trial Manager

Clinical Research OperationsUpdated on Nov 11
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree or an equivalent combination of education and experience in a science or health-related field, including experience in oncology.
  • Demonstrable experience leading clinical aspects of studies across multiple countries in a dedicated clinical lead role at a CRO, pharmaceutical, or biotechnology company.
  • Significant clinical trial management experience in oncology.
  • Working knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines and the clinical development process.
  • Availability for domestic and international travel, including overnight stays.
  • Ability to communicate effectively in English.
  • Demonstrated computer skills with Microsoft Office, Microsoft Project, and PowerPoint, and software experience with clinical trial management systems (CTMS), electronic trial master files (eTMF), electronic data capture (EDC), and interactive voice/web response systems (IXRS).
  • Demonstrated ability to develop positive working relationships with internal and external organizations.
  • Core understanding of medical terminology and clinical trial activities related to executing a clinical development plan.
  • Mastery of ICH-GCP, company standard operating procedures, and regulatory guidance, and the ability to implement them.
  • Must be legally authorized to work in the country of employment without employer sponsorship.

Responsibilities

  • Manage and operationally deliver the clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data-cleaning activities, and close-out.
  • Execute assigned trials successfully and ensure completion of trial deliverables.
  • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in close collaboration with other functional team members.
  • Mentor and train team members.
  • Identify challenges to study timelines and deliverables and offer creative action plans to the team and sponsor.
  • Lead clinical research associates (CRAs) as they establish site relationships and provide high-quality oversight of monitoring, regulatory matters, investigational product (IP), site payments, and overall site correspondence.
  • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve client satisfaction.

Desired Qualifications

  • Experience with CAR-T and radiopharmaceuticals is a strong plus.

About the Company

Precision Medicine Group

Biomarker-driven clinical development services and consulting

Precision Medicine Group provides specialized life sciences services to pharma and biotech companies across the full product lifecycle, from preclinical work to post-launch commercialization. Its Precision for Medicine unit runs biomarker assays, supports cell and gene therapy logistics through Project Farma, and manages global clinical trials, with ApoCell bolstering biomarker sample collection and analysis. The company differentiates itself by offering an integrated, biomarker-centric platform that combines scientific services with regulatory support and market access under one umbrella. Its goal is to de-risk and accelerate development and commercialization of targeted therapies by identifying responsive patient populations and demonstrating value to payers.

Company size
1,001-5,000
Company stage
Acquired
Total funding
$310.2M
Headquarters
Bethesda, MD
Founded
2012

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