Clinical Trial Manager, Precision Medicine

Company: Progenity, Inc.
Location: San Diego
Posted on: February 22, 2021

Job Description:

Clinical Trial Manager, Precision Medicine Our mission at Progenity is simple: to help healthcare providers and patients prepare for life. We provide the most advanced molecular technology and the highest levels of service to guide patient care at critical life stages. We continually seek people with the motivation and skills to advance our mission. The Clinical Trial Manager (CTM) is responsible for the management of clinical studies within the Clinical Affairs Department. The CTM works closely with the Senior Director, R&D, study sites, CROs, and Clinical Affairs staff to ensure successful completion of all clinical activities and project deliverables within required timelines. Responsibilities include reviewing and developing Clinical Operations processes and procedures, determining appropriate use of resources to meet planned goals, completing project-level tasks as delegated by Sr. Management (SM), and direct or line management of CRAs and CTAs. RESPONSIBILITIES

• Interacts directly with Clinical Affairs staff (e.g., CRAs, CTAs), site staff, vendors in the U.S. (or worldwide, as necessary) to provide management of clinical trials.
• May work under the direction of a more senior Clinical Trial Manager.
• Manages key performance indicators and study metrics and prepares correspondence, spreadsheets and presentations to report progress on clinical operations tasks or benchmarks.
• Develops Clinical operations processes and procedures, including the Clinical Monitoring Plan and study specific CRA training materials. Ensures CRA compliance to the CMP, conducts CRA training, and maintains documentation of training.
• Communicates monitoring and site management updates and/or issues to team.
• Writes or contributes to the development of clinical protocols, amendments, clinical study reports, informed consent forms, case report forms (CRFs), instructions for use, and any other clinical research related documents.
• Assumes overall responsibility for site agreements, budget negotiations, regulatory approvals through Institutional Review Boards /Ethics Committees, development of recruitment strategies, and provision of clinical study materials.
• Convenes and leads inter and interdepartmental clinical research meetings, ensuring that colleagues are updated on all relevant issues.
• Ensures GCP compliance and smooth execution of assigned clinical research studies by overseeing all aspects of the research project, including site start-up activities, clinical site management, ethical review board information, management of the study Trial Master File and by closely managing the financials of the project.
• Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables. This includes developing clinical monitoring study tools and templates for monitors and site personnel.
• Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization.
• Oversees the clinical study data collection and curation process by developing monitoring strategies and data-management strategies that govern clinical data integrity.
• Promotes operational efficiency, teamwork and high morale among CRAs and CTAs.
• Proactively prevents and identifies issues related to the clinical project, including study processes, monitoring or site issues.
• Works with Senior Management to identify, hire and oversee CROs, vendors and/or study suppliers.
• Works closely with department management for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary.
• Direct or line management of CRAs and CTAs. This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities, as deemed necessary.-- REQUIREMENTS
  • Bachelor's or higher degree required.
  • 6+ years of clinical/pharmaceutical industry/CRO experience/academic experience in various study management functions is required.
  • Ability to travel up to 20% of the time.
  • Clinical Operations experience managing Clinical Studies in early phases of clinical drug or device development (e.g., women's health, prenatal, pediatric, and/or oncologic development) is required.
  • Advanced knowledge of clinical research practices, FDA and ICH regulations, GCP, clinical study design and documentation, and conduct of clinical trials.
  • Advanced knowledge of clinical monitoring, management and trial design.
  • Advanced knowledge of clinical trial databases.
  • Strong interpersonal, communication (written and verbal), and organizational skills.
  • Demonstrates ability to work independently as well as part of a multi-functional study team.
  • Able to motivate a team to work effectively under a changing environment.
  • Able to solve problems under pressure.
  • Self-motivated and able to work effectively in a matrix/team environment.
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar databases required.
  • Ability to think strategically in order to improve current processes. Posted 8 Days Ago Full time R1189 About Us Progenity, Inc., is a public company providing complex molecular and specialized diagnostic tests to clinicians with a focus on clear, actionable results that enable informed medical decisions.
    
    At Progenity, we are committed to providing our clients with accurate, timely results, and the highest level of service in the industry. And we're equally committed to cultivating our employees by giving them opportunities to grow and perform to their fullest potential. We continually seek individuals with the motivation and skills to succeed.

Keywords: Progenity, Inc., San Diego , Clinical Trial Manager, Precision Medicine, Executive , San Diego, California