Clinical Trials Program Manager

Organization
HealthTell, Inc
Job Location
2420 Camino Ramon
San Ramon, CA 94583
Salary
DOE
Benefits

Full Comprehensive Benefits with 5 weeks of PTO.

Job Description

The Clinical Trials Project Manager (CPM) works closely with a study’s Principal Investigator to form the Study Management Team (SMT) for each protocol. You will be responsible for the overall planning, execution, and management of studies as well as participate in organizational process improvement initiatives.

Responsibilities (Primary):

  • Work with the Principal Investigator and collaborators to develop protocols and all documents required to initiate and conduct clinical studies, including informed consent forms, investigator brochures, case report forms, study procedure manuals, etc.;
  • Select and manage external service providers;
  • Ensure that clinical study timelines are consistent with company’s goals;
  • Help select study investigators/sites and evaluate adequacy to perform research and meet study timelines;
  • Manage studies to meet enrollment goals;
  • Generate and maintain study timelines. Identify and timely communicate trial issues that will impact budget, resources and/or timelines;
  • May participate in oversight monitoring activities, as needed;
  • Previous on-site monitoring experience is required;
  • Contribute to wider organizational goals and/or activities as assigned;
  • Work with the Principal Investigators to ensure the study remains within forecasted budget and escalate as needed.
  • Travel up to 25% may be required
Requirements

Requirements:

  • BS/BA in Life Science or related discipline.   RN degree or a degree in a healthcare related field or the life sciences is desirable but not mandatory;
  • 10+ years applicable industry experience in drug development, including prior site monitoring experience; Multinational Phase III Urology or Oncology experience preferred but not required.
  • Licenses or Certifications: Clinical Research certification preferred, but not required.
  • Previous on-site monitoring experience is required.
  • Relevant experience in clinical study planning, documenting, monitoring and execution.
  • Must be self-motivating and be able to follow directions precisely, prioritize and manage a large volume of work, and show attention to detail.
  • Thorough knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials;
  • Proficiency with word processing, spreadsheet, database, and presentation software and with filing (archiving) systems.
  • Strong interpersonal skills and professional attitude are essential as this individual interacts with many people of varying levels of responsibility for clinical studies and business performance.
  • Excellent communication and interpersonal skills.
  • Must be able to write clearly and summarize information effectively.

 

About Our Organization

About HealthTell:

HealthTell is a Life Sciences and Biotechnology company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, monitoring, and progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images.

HealthTell will empower physicians to make more informed decisions by providing the medical community with tools that will facilitate improved outcomes for patients with chronic diseases. Over 170 million people, in the US alone, are affected by chronic and debilitating diseases that create significant economic burden totaling over a trillion dollars. HealthTell is committed to improving the lives of patients through the power of ImmunoSignature™ Technology.

HealthTell is an equal opportunity employer.

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