Senior Clinical Trial Manager, Renal, Home-Based USA, IQVIA Biotech
Location: Los Angeles
Posted on: September 25, 2022
IQVIA Biotech is seeking a Senior Clinical Trial Manager
- 2+ years of prior trial management experience
- Cardiovascular/Renal/Metabolic is required.
- Prior experience in Internal Medicine, CNS or Dermatology also
preferred.BASIC FUNCTIONS:Responsible for the successful planning,
implementation and execution of contracted clinical monitoring
activities. Functionally responsible for all clinical monitoring
team members throughout the duration of each clinical trial.
Assures clear client and internal team communication, process
documentation, and compliance with Good Clinical Practices and
procedures set forth by IQVIA Biotech and its clients.ESSENTIAL JOB
FUNCTIONS, DUTIES AND RESPONSIBILITIES:Responsible for all
activities related to implementation and execution of clinical
studies that include:Client Duties/Responsibilities:
- Work with Project Manager (PM) to define program targets for
clinical monitoring staff and assure work is documented within
contracted project scope. Communicate and document all interactions
with client as required by SOP.
- Serve as client advocate within IQVIA Biotech.
- Develop and implement Clinical Monitoring Plan.Team
Duties/Responsibilities:Responsible for assuring needs of clinical
sites are met by facilitating clinical monitoring processes,
including:Coordinate site management activities:
- Site identification, recruitment, and selection.
- Regulatory document collection and review.
- Overall scheduling and management of all site visits.
- Develop site/monitoring tools and training materials.
- Review and identify trends in enrollment and data entry at
sites and proactively interface with clinical monitoring team and
client to identify solutions.Coordinate and oversee daily
operations of clinical monitoring team:
- Set and enforce project timelines with the assigned study
- Coordinate remote review of clinical data within EDC
- Oversee monitoring visit schedule to ensure compliance with
frequency set forth in contract.
- Review and approve trip reports and follow-up letters within
- Schedule and manage weekly CRA project team meetings.
- Ensure CRAs assigned to team receive therapeutic and
- Manage quality and regulatory compliance among clinical
monitoring team and investigational sites.Manage project milestones
and proactively address deficiencies:
- Attend and provide information at monthly projections
- Attend and provide information at weekly client
- Assist Project Manager in identifying Out of Scope activities
and assuring that such activities do not begin until the client
provides authorization.Manage CRA performance:
- Define and implement functional standards, goals, and
expectations with clinical monitoring team.
- Serve as CRA mentor and perform accompanied field assessment
visits as required.
- Participate in the performance appraisal program by providing
timely and accurate feedback regarding the performance of each
respective CRA.Documentation Duties/Responsibilities:
- Assure that the appropriate IQVIA Biotech and/or sponsor SOPs
- Ensure all project documentation is appropriately filed per
IQVIA Biotech SOPs.
- Assist PM in preparation of audit responses, as
- Assist PM with preparation of information for inclusion in
monthly report to client.Budget/Contract Duties/Responsibilities:
- Assist PM in review of project budgets, monitoring costs,
potential overruns and propose/implement cost effective
- Define the scope of work with the client and clinical
- Assist PM in identifying and generating changes in scope and
notify client of potential changes in scope.
- Review and approve CRA travel expenses and time
sheets.KNOWLEDGE, SKILLS & ABILITIES:
- Thorough knowledge of clinical research process.
- Strong communication skills (verbal and written) to express
- Excellent organizational and interpersonal skills.
- Positive attitude and ability to interact with all levels of
staff to coordinate and execute study activities.
- Ability to manage multiple priorities within various clinical
- Ability to reason independently and recommend specific
solutions in clinical settings.
- Understanding of basic data processing functions, including
electronic data capture.
- Working knowledge of current ICH GCP guidelines and applicable
- Ability to work independently, prioritize and work with a
matrix team environment is essential.
- Working knowledge of Word and Excel.
- Prior experience in electronic data capture (EDC)
- Able to mentor CRAs and more junior Clinical Trial
- Able to qualify for a major credit card.
- Valid drivers license; ability to rent automobile.
- Willingness and ability to travel domestically and
internationally, as required.CRITICAL JOB FUNCTIONS IN ACCORDANCE
WITH ADA CRITERIA:
- Ability to travel domestically and internationally
- Very limited physical effort required to perform normal job
dutiesMINIMUM RECRUITMENT STANDARDS:
- BS/BA (or equivalent) in one of the life sciences and a minimum
of 4 years direct experience in clinical studies
- Minimum of 4 years as a Clinical Monitor/CRA, as well as
experience in data handling or analysis
- Minimum of 2 years as a successful Lead CRA or Clinical Trial
- Equivalent combination of education, training and
experienceCLASSIFICATION:This position is classified as exempt
under the Fair Labor Standards Act; employees are not eligible for
overtime compensation.IQVIA is a leading global provider of
advanced analytics, technology solutions and clinical research
services to the life sciences industry. We believe in pushing the
boundaries of human science and data science to make the biggest
impact possible to help our customers create a healthier world.
Learn more at https://jobs.iqvia.comWe are committed to providing
equal employment opportunities for all, including veterans and
candidates with disabilities. https://jobs.iqvia.com/eoeAs the
COVID-19 virus continues to evolve, IQVIAs ability to operate and
provide certain services to customers and partners necessitates
IQVIA and its employees meet specific requirements regarding
Keywords: IQVIA, Los Angeles , Senior Clinical Trial Manager, Renal, Home-Based USA, IQVIA Biotech, Executive , Los Angeles, California
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