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Takeda Pharmaceuticals Sr. Manager, Clinical Data Standards/ Standards Tools & Technology Lead - Remote US in Des Moines, Iowa

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Job Description

Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases, and vaccines. Boston (Massachusetts) is the R&D headquarters.

Clinical Data Sciences (CDS) at Takeda:

Key to Takeda’s success, the Clinical Data Sciences team provides strategic planning, integration, execution, build, and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review, and supporting downstream transformation and analysis.

Clinical Data Sciences is comprised of the Clinical Data Engineering and Clinical Data Standards teams. The Clinical Data Standards team provides the standards for clinical data operation and ensures consistency to standards in Takeda’s data flow, and the Clinical Data Engineering team drives the data architecture for clinical data. Clinical Data Standards also provide support to exploratory and specialty data for the purposes of data modeling, simulation, and analysis.

Clinical Data Standards Technology Lead, Data Science Institute (DSI):

Key to Takeda’s success is the Clinical Data Standards team. The Clinical Data Standards Governance team provides strategic planning, integration, execution, build, and oversight of clinical data standards deliverables. Leads the governance of clinical data standards across all therapeutic areas along the clinical data value chain. The Clinical Data Standards team creates innovative ways to optimize standards deliverables to reduce timelines from protocol finalization to submission.

Within Clinical Data Sciences, the Clinical Data Standards Technology expert will lead technical projects and contribute to some topics in governance team meetings. You will be a member of Takeda’s dedicated and highly effective Clinical Data Standards team in Data Science organization. You will provide leadership in the planning and execution of Takeda’s clinical Research supporting the clinical data standards process. You will ensure the efficient and collaborative conduct of Standards governance processes for Data Standards governance boards, and for monitoring the operational effectiveness of the committees and boards through regular monitoring and analysis of operational metrics. You will succeed by developing and maintaining collaborative partnerships with other functional and TAU heads.

As an advisor and an expert, you will be able to build and leverage constructive relationships across the organization to achieve Clinical Data Standards goals and objectives. You will be entrusted with driving data-driven excellence through our governance processes to benefit Takeda’s portfolio of products and projects. Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.

Key Accountabilities:

  • Identify opportunities, develop and deploy tools and approaches to correct and optimize areas of redundancy or weakness in existing or proposed processes for cross-governance and data standards review, with a primary focus on (meta)data quality and speed of delivery.

  • Develop tools for standards development, currently SAS is mostly used, but experience with other software is welcomed

  • Create automated mechanisms to evaluate standards conformance.

  • Participate in the evaluation of existing and potential tools that have touchpoints for Standards (data conversion, MDR and more)

  • Develop tools to measure standards utilization in the various studies across therapeutic areas.

  • Ensure appropriate validation approach is agreed upon and implemented, user documentation and training(s) are developed for technical deliverables

  • Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.

  • May lead the assessment, implementation, integration, and governance of systems and tools to support, manage, govern and report on standards.

  • Build strong and productive working relationships with customer and stakeholder groups both internal and external to

  • Assists with quality review of the above activities performed by any external vendor, as needed.

  • Adhere to SOPs for computer system validation and all health authority, ICH (International Council for Harmonization) GCP (Good Clinical Practice) regulations.

  • Performs other duties as assigned within timelines, including assisting with study support and content creation activities at busy times

Educational Qualification:

  • Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology, or other health-related field or equivalent experience that provides the skills and knowledge necessary to perform the job.

Experience:

  • Minimum of 5 years experience in clinical data collection instruments or similar applications in a programming or administration capacity. Minimum of 1-year experience with Medidata Rave and/or Rave certification.

  • Knowledge of at least one clinical data management system and/or working knowledge of programming language.

  • Must understand database concepts. Knowledge of XML, ALS, and MDR preferred.

  • Strong working knowledge of clinical trial terminology and Architect Loader Specification expected.

  • Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively.

  • Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Strong knowledge of MS Word, Excel, PowerPoint, Access, and Outlook.

  • 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 learning new technologies and systems

  • Good knowledge of office software (Microsoft Office).

Behavioral Competencies:

  • Is comfortable with ambiguity.

  • Excellent teamwork, organizational, interpersonal, conflict resolution, and problem-solving skills.

Job Complexity:

  • Low-Medium complexity project.

  • Occasional domestic/international travel to other Takeda sites, strategic partners, and therapeutic area events may be required.

Supervision:

  • Supervision required, should be able to function collaboratively (with guidance) with all levels of employees.

License/Certifications:

  • Preferred to have Rave Study Builder Certification.

Physical Demands:

  • Ability to sit and stand for long periods of time.

  • Carrying, handling, and reaching for objects.

  • Manual dexterity to operate office equipment i.e. computers, phones, etc.

Travel Requirements:

  • Requires approximately 1-2 domestic trips annually and up to 1 international trip.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Base Salary Range $130,200.00 - $186,000.00, based on the 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.

This posting is made in compliance with Colorado’s Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

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

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