Manager/Senior Manager, Clinical Data Validation Engineer
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
- 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.
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.
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