Manager, Clinical Data Validation Engineer

Takeda Pharmaceuticals • Cambridge, MA, United States • $200k - $250k / year • 2w ago

Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Clinical Data Validation Engineer in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

OBJECTIVES:

The Clinical Data Validation Engineer (DVE) group leads validation and reconciliation efforts of collected data, both internally and externally, by programming data validation listings, reconciliation checks, and reports in a controlled and consistent manner. The DVE team works alongside the other teams to ensure adherence to Takeda standards and GCP principles. DVEs are vital to all data cleaning and reconciliation efforts and work cross-functionally with all members of Clinical Study teams to foster an environment of quality and efficient specifications and documentation to support audit-readiness and ICH compliance.

ACCOUNTABILITIES:

Key Accountabilities:

Program study level clinical data validation checks, reconciliation listings and related data cleaning reports adhering to internal processes, approved standards and specifications provided by internal stakeholders.
Partner closely with internal/external stakeholders and data engineers in a collaborative manner to ensure proper specification and testing documentation.
Ensure accurate delivery of all data validation tasks adhering to established timelines and internal processes.
Participate in the development of new processes and best practices, and assist with providing training and awareness to other business groups and functions, affected by these new activities and ways of working.

Additional Activities:

Assists with quality review of above activities performed by a vendor, as needed.
Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Qualifications:

Bachelor's degree plus minimum of 5+ years’ experience in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience.
Experience with EDC build, Data Management, and EDC extraction configuration.
Knowledge of data flow between clinical data management systems, vendor devices and CDR.
Knowledge of clinical database systems (Metadata Rave, Veeva, InForm) preferred.
Experience with one of these languages: SQL, SAS, R, Python.
Understanding of SDTM.
Strong working knowledge of clinical trial terminology and data transfer specification is expected.
Demonstrated ability to lead projects and work groups. Strong project management skills.
Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands.
Ability to work independently, take initiative and complete tasks to deadlines.

Special Skills/Abilities:

Strong attention to detail, and organizational skills.
Good time management skills.
Quick learner and comfortable asking questions, learning new technologies and systems.
Good knowledge of office software (Microsoft Office).
Understanding of AWS/Data bricks concepts.

Preferable but not required: