Job description
Immediate openings available for Sr. Clinical Trial Managers/
Clinical Trial Managers with #Oncology clinical study experience;
CAR T trial experience a plus.
Why Clinical Trial Managers join IQVIA Biotech? We provide a
comprehensive onboarding program. Instructor lead Biotech specific
project training. Dedicated therapy focus. Manager supported career
development planning. Family First Work Life Balance. Close
collaborative client relationship management with biotech & startup
companies.
Would you like to know more? Contact me at
Angela.Lucas@IQVIA.com or follow the link to apply.
OurTrial Managers are 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.
- Prior experience as a Clinical Research Associate.
- 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.
- 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 with a
minimum of 4 years direct experience in clinical studies or
equivalent level of education and experience.
- Minimum of 4 years as a Clinical Monitor/CRA, as well as
experience in data handling or analysis.
- Minimum of 2 -3 years as a successful Clinical Trial
Manager.
- Excellent verbal and written communication skills.
- 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.
- Therapeutic Knowledge- CAR T cell therapy study experience
required; additionally 2 years of solid tumor, hematologic oncology
and oncology phase I experience strongly preferred
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 67,000+
employees around the world who apply their insight, curiosity and
intellectual courage every step of the way. Learn more at
jobs.iqvia.com.
IQVIA is an EEO Employer - Minorities/Females/Protected
Veterans/Disabled
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 workday_recruiting@iqvia.com to arrange for such an
accommodation.
