Senior Clinical Trial Manager, Internal Medicine, IQVIA Biotech
Posted on: January 16, 2022
IQVIA Biotech is seeking a Senior Clinical Trial Manager to join
our team! Previous Clinical Trial Management experience
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:
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.
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
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
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 meetings.
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
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
Participate in the performance appraisal program by providing
timely and accurate feedback regarding the performance of each
Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are
Ensure all project documentation is appropriately filed per IQVIA
Assist PM in preparation of audit responses, as appropriate.
Assist PM with preparation of information for inclusion in monthly
report to client.
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
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
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
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) 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,
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally
Very limited physical effort required to perform normal job
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
Equivalent combination of education, training and experience
This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime
At IQVIA, 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. The advanced analytics,
technology solutions and contract research services we provide to
the life sciences industry are made possible by our 70,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, status as a protected
veteran, or any other status protected by applicable law.
IQVIA, Inc. provides reasonable accommodations for applicants with
disabilities. Applicants who require reasonable accommodation to
submit an application for employment or otherwise participate in
the application process should contact IQVIA's Talent Acquisition
team at firstname.lastname@example.org to arrange for such an
Keywords: IQVIA, Philadelphia , Senior Clinical Trial Manager, Internal Medicine, IQVIA Biotech, Healthcare , Mantua, Pennsylvania
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