Manager EDC Data Acquisition Expert
Company: Disability Solutions
Location: Spring House
Posted on: April 10, 2025
Job Description:
At Johnson & Johnson, we believe health is everything. Our
strength in healthcare innovation empowers us to build a world
where complex diseases are prevented, treated, and cured, where
treatments are smarter and less invasive, and solutions are
personal. Through our expertise in Innovative Medicine and MedTech,
we are uniquely positioned to innovate across the full spectrum of
healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.comJob Function: Data Analytics & Computational
SciencesJob Sub Function: Clinical Data ManagementJob
Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey,
United States of America, Spring House, Pennsylvania, United States
of America, Titusville, New Jersey, United States of AmericaJob
Description:Our expertise in Innovative Medicine is informed and
inspired by patients, whose insights fuel our science-based
advancements. Visionaries like you work on teams that save lives by
developing the medicines of tomorrow.Join us in developing
treatments, finding cures, and pioneering the path from lab to life
while championing patients every step of the way. Learn more at We
are searching for the best talent for Manager EDC Data Acquisition
Expert to be in Spring House, PA or Titusville, NJ.Purpose: The
Manager Data Management is an experienced individual with an
in-depth understanding of data management and/or acquisition
strategies, practices, methods, processes, and technologies. In
this role the Manager Data Management directly contributes to
delivery of the J&J R&D through effective leadership and
accountability for Data Management delivery on clinical development
programs and/or strategic innovation programs and projects. This
position reports to Data Management and Central Monitoring
Functional Leadership and represents Data Management in cross
functional discussions, influencing key stakeholders and driving
strategic discussions and decisions. This position plays an
important role in the growth and development of the group and
contributes to organizational effectiveness, transparency, and
communication as a matrix leader driving projects, innovation, and
capability growth and/or as a People Manager, through the
recruitment, onboarding, performance management, and development of
people while building an inclusive and diverse working environment.
In addition, the Manager Data Management plays a role in change
leadership and driving the enhancement of functional, technical
and/or scientific capabilities, processes, and tools within the
function. This position develops strong and productive working
relationships with key stakeholders within IDAR and Global
Development, in addition to broader partners and external
suppliers.You will be responsible for:
- Drive the strategy and planning, execution, and completion of
all data management activities and deliverables within assigned
scope ensuring quality, compliance standards, consistency, and
efficiency.
- Proactively evaluate and manage resource demand, allocation,
utilization, and delivery to meet current and future business
needs. Ensure timely and effective maintenance of functional
planning systems.
- Effectively manage issue escalations, adopting appropriate
escalation pathways.
- Anticipation, early detection, prevention and management of
risks and issues impacting departmental deliverables and
activities.
- Collaborate with internal cross-functional colleagues and
external partners to define the data integration strategy for
assigned programs/projects
- Collaborate with external partners on data management related
deliverables including codevelopment programs.
- Ensure staff compliance with department SOPs, policies, and
regulatory guidance documents.
- Contribute to the development and maintenance of departmental
policies, procedures, training, and standards.
- Contribute to the development of functional vendor contracts
and oversee of delivery in line with agreed milestones and scope of
work, R&D business planning and budget estimates.
- Contribute to the enhancement of functional, technical and/or
scientific capabilities, processes, and tools within data
management.
- Contribute to the external industry and/or regulatory
environment through active engagement in industry forums and
working groups.
- May serve as a business process or system owner for Data
Management Processes or Systems.
- May provide people leadership with responsibility for hiring,
attracting, and retaining top talent, performance management,
career development and HR administration for direct reports.This
position may be specialized into the following roles based on
business needs: Data Management Leader, Data Acquisition LeaderData
Management Leader role-specific responsibilities:
- Accountable for Data Management delivery within assigned
area/program --- Serve as the Data Management primary point of
contact to the Global Program Leader (GPL) for assigned
program/region.
- In collaboration with Functional Leadership, define the data
management strategy and sourcing/operating model for the assigned
programs.
- Take a leadership role for data management related aspects of
regulatory agency inspections and internal audits. Coordinate real
time inspection readiness for all data management
deliverables.
- If people leader, typically provides people management for
Global Data Managers and/or Clinical Data Managers.Data Acquisition
Leader role-specific responsibilities:
- Accountable for Clinical Data Acquisition delivery within
assigned area and scope including setup and management of data
collection tools and/or acquisition of external data streams
including but not limited to EDC, ePRO, eSource, EHR, Real World
data and traditional and novel clinical data streams.
- Serve as the Clinical Data Acquisition primary point of contact
for assigned area and scope.
- In collaboration with Functional Leadership, define the data
acquisition strategy and sourcing/operating model for assigned
programs.
- Support data acquisition related aspects of regulatory agency
inspections and internal audits. Coordinates real time inspection
readiness for all data acquisition deliverables.
- If people leader, typically provides people management for Data
Acquisition Experts within assigned area and scope.Principal
Relationships:
- Reports into people manager position within functional area
(e.g., Director Data Acquisition, Data Management Therapeutic Area
Head).
- Functional contacts within IDAR include but not limited to:
Leaders and/or leads in Data Management and Central Monitoring,
Clinical and Statistical Programming, Clinical Data Standards,
Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system
support organizations.
- Functional Contacts within J&J Innovative Medicine (as
collaborator or peer) include but not limited to: Global Program
Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams,
Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic
Partnerships, Human Resources and Project Coordinators.
- External contacts include but not limited to: External partners
and suppliers, CRO management and vendor liaisons, industry peers
and working groupsEducation and Experience RequirementsRequired:
- Bachelor's degree (e.g., BS, BA) or equivalent professional
experience is required, preferably in Clinical Data Management,
Health or Computer Sciences. Advanced degrees preferred (e.g.,
Master, PhD).
- Approx. 6 years of experience in Pharmaceutical, CRO or Biotech
industry or related field or industry.
- In-depth knowledge of data management practices (including
tools and processes).
- In-depth knowledge of regulatory guidelines (e.g.,
ICH-GCP).
- Project, risk, and team management and an established track
record leading teams to successful outcomes.
- Excellent planning and coordinating of Data Management or Data
Acquisition strategy and delivery.
- Experience collaborating with multi-functional teams in a
matrix environment and partnering with/managing stakeholders,
customers, and vendors.
- Excellent communication, leadership, influencing and
decision-making skills, and demonstrated ability to foster team
productivity and cohesiveness adapting to rapidly changing
organizations and business environments.
- Excellent written and verbal communications skills (in
English).Preferred:
- If Principal Responsibilities include people leadership; strong
people management skills including staff performance management and
people development.
- Innovative thinking to allow for optimal design and execution
of clinical development strategies.
- Development and implementation of a business change/innovative
way of working.
- Experience working with data from EHR/EMR, Digital Health
technologies, Real-World Data, or similar, eDC systems, eDC
integration tools, and general data capture platforms.Johnson &
Johnson is an Equal Opportunity Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, age,
national origin, disability, protected veteran status or other
characteristics protected by federal, state or local law. We
actively seek qualified candidates who are protected veterans and
individuals with disabilities as defined under VEVRAA and Section
503 of the Rehabilitation Act.Johnson and Johnson is committed to
providing an interview process that is inclusive of our applicants'
needs. If you are an individual with a disability and would like to
request an accommodation, please email the Employee Health Support
Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be
directed to your accommodation resource.The anticipated base pay
range for this position is :$115,000-$197,800Additional Description
for Pay Transparency:The Company maintains highly competitive,
performance-based compensation programs. Under current guidelines,
this position is eligible for an annual performance bonus in
accordance with the terms of the applicable plan. The annual
performance bonus is a cash bonus intended to provide an incentive
to achieve annual targeted results by rewarding for individual and
the corporation's performance over a calendar/performance year.
Bonuses are awarded at the Company's discretion on an individual
basis. Employees and/or eligible dependents may be eligible to
participate in the following Company sponsored employee benefit
programs: medical, dental, vision, life insurance, short- and
long-term disability, business accident insurance, and group legal
insurance. Employees may be eligible to participate in the
Company's consolidated retirement plan (pension) and savings plan
(401(k)). This position is eligible to participate in the Company's
long-term incentive program. Employees are eligible for the
following time off benefits: Vacation - up to 120 hours per
calendar year Sick time - up to 40 hours per calendar year; for
employees who reside in the State of Washington - up to 56 hours
per calendar year Holiday pay, including Floating Holidays - up to
13 days per calendar year of Work, Personal and Family Time - up to
40 hours per calendar year Additional information can be found
through the link below.
http://www.careers.jnj.com/employee-benefits The compensation and
benefits information set forth in this posting applies to
candidates hired in the United States. Candidates hired outside the
United States will be eligible for compensation and benefits in
accordance with their local market.
Keywords: Disability Solutions, Philadelphia , Manager EDC Data Acquisition Expert, Executive , Spring House, Pennsylvania
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