Manager/Senior Manager, Clinical Data Validation Engineer - REMOTE
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: March 13, 2023
Job Description:
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Job Description
About the role:
At Takeda, we are a forward-looking, world-class R&D
organization that unlocks innovation and delivers transformative
therapies to patients. By focusing R&D efforts on four
therapeutic areas and other targeted investments, we push the
boundaries of what is possible in order to bring life-changing
therapies to patients worldwide.
Join Takeda as a Manager/Senior Manager, Clinical Data Validation
Engineer where you will work with Data engineering team, standards
and Clinical Data Management teams in the development of data
cleaning/quality checks, study status metrics, visualizations and
monitoring reports standards. You will also lead and organize
programming activities for assigned clinical studies and
non-clinical data cleaning activities. Develop parameterized data
cleaning reports to support data review plan.
How you will contribute:
- Create data cleaning reporting solutions with appropriate
oversight that support the quality and timely delivery of data
cleaning, study status metric, and monitoring reports and
visualizations required per standard and study specific data review
plans.
- Create any needed documentation for reports throughout the
lifespan of the study and/or asset for all deliverables
- Develop library of reusable checks working closely with data
engineers and config specialists.
- Collaborate with cross functional teams in creating business
rules and automated check library across TAU.
- Develop SOPs and working practices for the team.
- Complies with applicable SOPs and work practices
- Serves as a technical resource for creating data analytics to
help with data validation and cleaning
- Supports knowledge development of others on reporting tools
that support the accuracy and integrity of study data
- Provide programming expertise for data cleaning to efficiently
ensure high quality data
- Enhances available reporting tools/macros/libraries or creates
new ones to support the review of clinical trial data and trial
status information for cross-functional use and provides input on
data management reporting standards as required
- Ensure accurate delivery by creating macros for Standard
listings for the department based on specifications.
- Creates and tests listings for data review.
- Develop programs that generate CRF and Query metrics, including
ad-hoc Sponsor and internal programming requests.
- Ensures operational excellence in collaboration with partners
and colleagues for application of standards and develop data
cleaning reports in support of the data review plan, in
collaboration with the Clinical Data Management and medical
reviewers
- Directly supports knowledge development of others on data
reporting and reporting tools that support the accuracy and
integrity of study data
- Identifies existing process/product improvements
- Develops innovative, advanced new concepts that improve
processes
- Recognizes development needs and identifies/creates development
opportunities within team
- Supports the development of the Data Management Programming
talent base and identifies development needs within the area of
responsibility
- Ability to setup and configure analytics for coding reports,
safety review and any risk-based monitoring activities Minimum
Requirements/Qualifications:
- MS with 6+ years of industry related experience for Senior
Manager.
- BS with 8+ years of industry related experience for Senior
Manager.
- BS with 5+ years of industry related experience for
Manager.
- Advanced degree preferred.
- Proven track record of contributing to business process
transformation and organizational culture change as well as
providing programming expertise on programs with complex business
deliverables
- Experience leading business process transformations and
organizational culture change as well as contributing to
programming expertise on programs with complex business
deliverables
- Operational experience in pharmaceutical drug development with
significant direct exposure to clinical development and data
operations required for the reporting of clinical trial data (e.g.
data review, regulatory submissions, safety updates, etc.)
- Understanding of regulatory requirements and relevant data
standards; CDISC knowledge and experience are preferable
- Strong communication (written and oral), leadership,
decision-making, influencing, negotiation, and project management
skills
- Demonstrated experience managing complex projects and
developing successful partnerships within and across functional
areas
- Technical skills and experience using relational databases
(e.g. MS SQL Server, Redshift, or Oracle),
- EDC build and/or clinical data management experience
preferred
- Experience in AWS preferred
- Experience setting up automated validation is preferred
- Knowledge of Data lake and creating interactive Dashboards are
preferred
- Proficiency in the use of Microsoft Office Suite of tools
(Outlook, Word, Excel, etc.)
- Programming, specifically SAS, Python and R, and other
visualization tools hands-on experience (BOXI, Spotfire, Tableau,
RShiny, JReview, Plotly, Elluminate) What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement More about us:
At Takeda, we are transforming patient care through the development
of novel specialty pharmaceuticals and best in class patient
support programs. Takeda is a patient-focused company that will
inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating
careers, encourages innovation, and strives for excellence in
everything we do. We foster an inclusive, collaborative workplace,
in which our teams are united by an unwavering commitment to
deliver Better Health and a Brighter Future to people around the
world.
- This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
- Preference will be given to candidates with a remote location
near the corporate office in Boston, Massachusetts.
- Base Salary Range: $102,200 to $146,000 based on candidate
professional experience level. Employees may also be eligible for
Short-term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
Off.
- The final salary offered for this position may take into
account a number of factors including, but not limited to,
location, skills, education, and experience. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce
and providing equal employment opportunities to all employees and
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, gender expression,
parental status, national origin, age, disability, citizenship
status, genetic information or characteristics, marital status,
status as a Vietnam era veteran, special disabled veteran, or other
protected veteran in accordance with applicable federal, state and
local laws, and any other characteristic protected by law.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Jersey City , Manager/Senior Manager, Clinical Data Validation Engineer - REMOTE, Executive , Jersey City, New Jersey
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