Senior Clinical Project Manager, IQVIA MedTech
Posted on: May 14, 2022
IQVIA MedTech is growing & we are hiring for Senior Clinical
Project Managers to join us! Ideal candidates will have
cardiovascular device experience as a project manager. This role
can be home-based anywhere in the United States.
Responsible for the successful planning, implementation and
execution of contracted activities. Assures the accurate transfer
of contracts from proposal through project completion. Functionally
responsible for all team members throughout the duration of each
clinical trial. Assures clear client communication, process
documentation, and compliance with Good Clinical Practices (GCP)
and procedures set forth by IQVIA Biotech and sponsors. Supports
the department director in development of functional training,
mentoring, and definition of standards and execution of department
goals including process improvement.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation of
clinical studies including: Manages projects of full scope regional
and global projects. Responsible for project team leadership
Responsible for building and maintaining positive client
Ability to negotiate with clients to assure IQVIA Biotech's
operational processes are maintained, projects are done within
Reviewing and identifying project study trends and proactively
responding to client and respective team members
Developing appropriate early warning systems of potential obstacles
to the successful completion of the projects; analyzes information
and develops innovative solutions to challenges
Identifying, define, document training requirements in LMS systems
and assure project level compliance with study specific training
Responsible for change management on all assigned projects
Responsible for assuring projects assigned are run according to
SOPs and WP as refined in the contract
Responsible for assuring project timelines are met as per
Responsible for identifying processes which need updating and
documenting that to the direct line manager or divisional lead
Responsible for maintaining client relationships for all assigned
work, keeping all project reporting current, and assuring executive
management is aware
In conjunction with management, assists with developing,
documenting, and updating internal processes and processes required
for consistency across programs such as SOPs, working practices,
and related quality assurance forms.
Provide other project support to Managers, as assigned
Oversee delegation of support staff activities, as necessary
Assists in the development and delivery of capability and proposal
defense presentations to prospective clients
Supports Contracts and Proposals with final project contract
execution and CIS documentation by the project team. Represents
senior management in negotiation of contracts as appropriate.
Participates in the performance appraisal program by providing
timely and accurate feedback regarding the performance of
respective team members at least annually
Maintains current knowledge of FDA regulations, and GCP and ICH
Guidelines for clinical research.
Responsible to maintain personal currency documentation for IQVIA
Biotech SOPs, CAPA completion and timesheet maintenance including
assurance or back-up PM staff at every instance of out of
KNOWLEDGE, SKILLS AND ABILITIES:
Thorough knowledge of clinical research process from Phase I
through regulatory submission
Strong communication skills (verbal and written) to express complex
Excellent and demonstrated organizational and interpersonal
Positive attitude and ability to interact with all levels of staff
to coordinate and execute study activities
Ability to manage multiple priorities within a variety of complex
Ability to reason independently for the purpose of assessing and
recommending specific solutions in clinical settings
Ability to set baseline targets, track trends and implement
Understanding of basic data processing functions, including
electronic data capture
Demonstrated problem-solving and financial negotiation skills
Working knowledge of current ICH GCP guidelines
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very limited physical effort required to perform normal job
Up to 20% travel may be required including international travel
Must be able to secure a credit card cosigned by IQVIA Biotech
MINIMUM RECRUITMENT STANDARDS:
Previous Management Requirements:
Nursing or University degree (US Bachelor Level or equivalent) in a
health-related field with at least five (5) years direct clinical
trial experience in a CRO or research-related organization with at
least two (2) years management experience OR
Equivalent level of education and experience.
Previous experience in managing people within a scientific/clinical
environment is required.
Demonstrated Clinical Monitoring and/or Data Management experience
Excellent verbal and written communication and presentation skills
Demonstrated financial management skills required
Ability to work independently, prioritize and work with in a matrix
team environment is essential.
Working knowledge of Word, Excel, and PowerPoint required.
Prior experience in electronic data capture preferred.
Ability to travel domestically or internationally as required.
US: This position is classified as exempt under the Fair Labor
Standards Act; employees are not eligible for overtime
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
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
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.
Keywords: IQVIA, Lancaster , Senior Clinical Project Manager, IQVIA MedTech, Healthcare , Lancaster, California
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