Sr. Clinical Project Manager/Clinical Project Manager (Home Based) - IQVIA Biotech
Company: IQVIA
Location: Orchard Park
Posted on: August 5, 2022
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Job Description:
**IQVIA Biotech is seeking a Sr. Clinical Project Manager or
Clinical Project Manager. Cardiovascular, Renal or Metabolic
experience a plus:****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.comWe are
committed to providing equal employment opportunities for all,
including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoeAs 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-statusEEO
Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, Buffalo , Sr. Clinical Project Manager/Clinical Project Manager (Home Based) - IQVIA Biotech, Executive , Orchard Park, New York
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