Sr Clinical Trial Manager, Cardiovascular/Renal/Metabolic, Home-Based USA, IQVIA Biotech
Company: IQVIA
Location: Saint Louis
Posted on: May 27, 2023
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Job Description:
IQVIA's Biotech Division is seeking a Sr Clinical Trial Manager
for a Home-Based role. Qualified candidates will have:
Strong Cardiovascular and/or Renal experience is REQUIRED
3+ years of clinical trial management experience from CRO
environment
Previous experience as a Global CTM.
Candidates should be willing to work in other therapeutic areas, as
needed.
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 team.
Coordinate remote review of clinical data within EDC system.
Oversee monitoring visit schedule to ensure compliance with
frequency set forth in contract.
Review and approve trip reports and follow-up letters within
required timeframe.
Schedule and manage weekly CRA project team meetings.
Ensure CRAs assigned to team receive therapeutic and
project-specific training.
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 meetings.
Attend and provide information at weekly client
teleconferences/team meetings.
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 are
followed.
Ensure all project documentation is appropriately filed per IQVIA
Biotech SOPs.
Assist PM in preparation of audit responses, as appropriate.
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 solutions.
Define the scope of work with the client and clinical monitoring
team.
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 complex
ideas.
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
trials.
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
regulations.
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) preferred.
Able to mentor CRAs and more junior Clinical Trial Managers.
Able to qualify for a major credit card.
Valid driver's 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
duties
MINIMUM 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
Manager.
Equivalent combination of education, training and experience
CLASSIFICATION:
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.com
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
https://jobs.iqvia.com/covid-19-vaccine-status
Colorado/California/Washington state Pay Transparency : The salary
range for this role is $117,200 - $146,500.The actual salary will
vary based on factors like candidate qualifications and
competencies. Certain roles are eligible for annual bonus, sales
incentives and/or stock. Benefits may include healthcare,
retirement, paid time off, and more.
IQVIA is a world leader in using data, technology, advanced
analytics, and expertise to help customers drive healthcare - and
human health - forward. Together with the companies we serve, we
are enabling a more modern, more effective and more efficient
healthcare system, and creating breakthrough solutions that
transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore
new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, St. Louis , Sr Clinical Trial Manager, Cardiovascular/Renal/Metabolic, Home-Based USA, IQVIA Biotech, Executive , Saint Louis, Missouri
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