Senior Project Manager/Project Manager III
Company: WuXi AppTec
Location: Plainsboro
Posted on: May 26, 2023
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Job Description:
Overview
WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a
global Contract Research Organization (CRO) providing a
comprehensive range of services in clinical development. We provide
Phase I to Phase IV clinical development services & BE
(Bioequivalence) , for products including pharmaceuticals,
biologics, and medical devices. With expertise spanning all major
therapeutic areas, we deliver the unique blend of an experienced
team, combined with the creativity, responsiveness, and customer
centric-focus of a highly nimble organization. This
forward-thinking approach has allowed us to work on a variety of
projects ranging from first-in-human products to marketed drugs and
devices.
Job Summary: The Senior Project Manager manages and coordinates
clinical and/or data project services for sponsors to assure
project/program milestones are met according to contract and
applicable regulations are followed.
Responsibilities
Essential Job Functions:
Provides operational support for Clinical Operations
Oversee all aspects of clinical research projects (primarily
inclusive of complex, full-service and/or global trials) in order
to assure applicable regulations, standard operating procedures and
sponsor requirements are met
Perform contract and financial management activities for assigned
trials and serve as central point of contact with sponsor for
project updates
Serve as supervisor, resource, mentor, trainer, and motivator to
team members
Participate in business development activities, including proposal
development and pricing and bid defense meetings, as required
Meet with resourcing lead and supervisor to assure project needs
are adequately met for all assigned projects
Perform training within company
High-quality deliverables, repeat business, and project
profitability
Responsible for the management of US and Global projects
Position requires employee be aware of budget constraints and
ensure that the team is informed of those constraints
Requires employee to monitor financials against those constraints
in order to maximize project profitability
Mismanagement of project could result in poor project
profitability, client dissatisfaction, and/or loss of repeat
business
Gives formal supervision to Research Associates
Provides leadership and coordination to matrix project team members
that may include Clinical Research Associates, Clinical Data
Analysts, vendors, contractors and consultants as required by the
project
Receives direct supervision from Associate Director, Clinical
Operations or above
Demonstrates problem solving ability, taking into consideration
time, financial, quality, and customer relations
Independently extrapolates and applies decisions from previous
discussions to new situations and recognizes the relevance from one
situation to the next
Requires only minimal supervision on project decisions that could
have substantial impact on clinical, data quality, or regulatory
issues
Works on routine assignments per written procedures, where ability
to recognize deviation from accepted practice is required.
Normally receives minimal instructions on routine work and detailed
instructions on new assignments.
Works under close supervision from supervisor or senior
personnel.
Performs support functions (e.g. Runner function) in the (fill in
Specific Dept.)
Ability to work in a team environment and independently as
required
May be required to work Holidays and weekends
May be required to work Overtime ( Remove only for Exempt
positions)
Contributes to the overall operations and to the achievement of
departmental goals
Perform job specific tasks in compliance with applicable
Regulations, International Standards, and WuXi AppTec Policies and
Standard Operating Procedures.
Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and
other applicable regulations [List as appropriate and could also go
under KSA's below]
Other duties as assigned
May be required to assist in other departments
Qualifications
Job Requirements
Experience / Education:
Minimum of 5 years related clinical research experience in CRO,
pharma, biotech/device company with 3 years of project management
experience or equivalent
Minimum of 3 years' experience directly managing professional level
individuals
Experience in leading multi-service project teams through a
complete clinical trial
Good knowledge of clinical, regulatory, and data aspects of trials
including, but not limited to field monitoring, data management,
biostatistics, and medical writing
Bachelor's degree preferred
Knowledge / Skills / Abilities:
Effectively communicates in clear, concise, professional manner
with employees and senior management within company and with peer
and senior level customer contacts
Communicates well both verbally and in writing and effectively
conveys issues and potential resolutions to team members and
supervisors
Demonstrates active listening and excellent interpersonal
communication skills and exhibits the ability to lead team using
appropriate motivational techniques, conflict management
approaches, and consistent integrity
Skilled at presenting topics to groups for the purpose of training,
bid defense meetings or other public speaking opportunities
Good working knowledge of physician care in hospitals, clinics, or
other healthcare settings
Advanced knowledge of FDA guidelines and review processes, IND and
NDA processes, and GCPs; project management skills including client
management, fiscal/contract management, and quality management; as
well as strong time management skills and the ability to thrive in
a stressful environment with multiple priorities
Demonstrates a high level of attention to detail and the ability to
interact professionally with clients, team members, and
investigational sites
Solid knowledge of computers and Microsoft Office Suite of products
as well as experience with tools specific to clinical trial
management (e.g. CTMS, EDC, IVRS, eTMF, etc.)
Travel is required 10% , Domestic/International, Daily /
Overnight
Must have a valid driver's license and the ability to rent a
car
Physical Requirements:
Must be able to work in an office environment, which has minimal
noise conditions
Ability to stand or sit for most of the work day
Must be able to perform some activities with repetitive motion,
such as keyboarding
This job description does not state or imply that the above are the
only duties and responsibilities assigned to this position.
Employees holding this position will be required to perform any
other job-related duties as requested by Management.
WuXi Clinical is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex, sexual orientation, gender identity,
national origin, or protected veteran status and will not be
discriminated against on the basis of disability.
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An Equal Opportunity Employer. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disabilityAn Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and
will not be discriminated against on the basis of disability
(https://careers-wuxiapptec.icims.com/connect?back=intro&findajob=1&in_iframe=1&hashed=-435740542)
Job Locations US
Job ID 2020-6840
Keywords: WuXi AppTec, Trenton , Senior Project Manager/Project Manager III, Executive , Plainsboro, New Jersey
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