Senior Clinical Project Manager, Home-Based - IQVIA Biotech
Company: IQVIA
Location: Port Saint Lucie
Posted on: May 29, 2023
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Job Description:
We're looking for a talented and energetic Sr. Project Manager
to join our IQVIA Biotech Internal Medicine Team. We value
applicants with diverse skillsets, varied therapeutic experience
and functional backgrounds. At IQVIA Biotech, we're bringing
something new to the industry. A flexible model,
therapeutically-aligned teams and dedicated resources working in a
transparent partnership designed specifically to help small and
midsized biotech companies move treatments forward. In this dynamic
role, you will utilize your knowledge to oversee clinical studies
within internal medicine TA's potentially including infectious
disease, gastrointestinal, respiratory, women's health, and rare
disease. Working in a friendly and supportive environment, you will
be recognized for your achievements and will have opportunities to
contribute to department growth. At IQVIA Biotech we believe our
employees are at their best when they bring their whole selves to
work. From camaraderie to professional development, working at
IQVIA Biotech provides unique opportunities to advance your career
alongside a group of diverse, talented colleagues.
POSITION TITLE: Senior Project Manager
REPORTS TO: Director, Project Management or Designee
BASIC FUNCTIONS:
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
relationships
Ability to negotiate with clients to assure IQVIA Biotech's
operational processes are maintained, projects are done within
scope
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
requirements
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
contract
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
office
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
ideas
Excellent and demonstrated 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 a variety of complex
clinical trials
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
mitigation plans
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
duties.
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
required.
Excellent verbal and written communication and presentation skills
required.
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.
CLASSIFICATION:
US: 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
New York City 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.
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, Port St. Lucie , Senior Clinical Project Manager, Home-Based - IQVIA Biotech, Executive , Port Saint Lucie, Florida
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