Clinical Trial Manager, Precision Medicine
Company: Progenity, Inc.
Location: San Diego
Posted on: February 22, 2021
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.
- 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
- 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
- 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
- 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
- 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
- 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.--
- 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
- 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
- Advanced knowledge of clinical trial databases.
- Strong interpersonal, communication (written and verbal), and
- 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
- Able to solve problems under pressure.
- Self-motivated and able to work effectively in a matrix/team
- Intermediate proficiency in Microsoft Word, Excel, and
PowerPoint, and some knowledge of Access or similar databases
- 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
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