Job description
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 and
procedures set forth by IQVIA Biotech and sponsors. Supports the
department director in development of functional training,
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:
- Knowledge of clinical research process from Phase I through
regulatory submission
- 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 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
- 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 a minimum of three (3) years direct
clinical trial experience in a CRO or research-related organization
with at least one (1) year management experience OR
- Equivalent level of education and experience.
- Previous experience in managing people within a
scientific/clinical environment is preferred.
Clinical Monitoring or Data Management experience required.
Excellent and demonstrated verbal and written communication and
presentation skills.
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.
- Experience in contract/timeline management preferred
- Excellent written and verbal communication skills required
- Ability to travel domestically or internationally as
required
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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
jobs.iqvia.com.
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 workday_recruiting@iqvia.com to arrange for such an
accommodation.
