Sr. Manager, Data Management

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us.

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Employee Value Proposition

Join Taiho Oncology as a Senior Manager, Data Management, where your expertise will drive innovation in data science, shape the future of Data Management, and contribute to groundbreaking research that advances patient care worldwide. In our dynamic, collaborative environment, we offer competitive compensation, comprehensive benefits, and opportunities for professional growth. Be part of a rapidly evolving organization that values your experience and empowers you to make a meaningful impact.

Position Summary

• This position assists coordination and management of the Taiho Oncology Inc., (TOI), clinical data management (CDM) activities performed by internal or various CRO teams for specific clinical programs. Responsibilities include setting and maintaining study CDM timeline, performing or overseeing study EDC set-up, managing CDM activities and deliverables, as well as carrying out hands-on work as a data manager as needed, and may also include leading or participating development of specific Taiho global/TOI CDM processes.
  
  

Performance Objectives

• Manage internal and external CDM resources to support specific clinical programs and studies.
• Ensure the quality and timelines of all CDM deliverables with specific clinical studies.
• Contribute to study design and conduct by providing relevant CDM input.
• Work as hands-on clinical data manager to support clinical studies from in reviewing and contributing to study protocol, CRF design, authoring/reviewing CRF completion guidelines, data management plan, data validation plan and specifications, and other CDM documents, AE/SAE reconciliation, AE and ConMed coding, data transfer, randomization blind breaking and to database lock, and study close.
• Participate in tasks enhancing CDM infrastructure, capacity and efficiency, especially in Medidata study-build, MedDRA and WHOdrug coding, etc.
• Keep abreast of oncology practices, competitive environment, regulatory or scientific trends, as well as general industry standards and regulatory requirements pertinent to CDM responsibilities.
• Collaborate closely with Taiho Pharmaceutical Company (TPC) Data Science colleagues to implement global standards and processes and may also lead on specific CDM standardization initiatives.
  
  

Education/Certification Requirements

• Bachelor's degree in life sciences or equivalent required, Master’s degree preferred.
  
  

Knowledge, Skills, And Abilities

• Minimum 6 years of hands-on DM experience in biopharmaceutical clinical research setting.
• Experience in oncology Phase I, II, and III studies preferred.
• Knowledge of oncology research standards and best practice in data collection methodology and operational approaches preferred.
• Knowledge of regulatory regulations and guidance, standard concepts, practices, and procedures relevant to clinical DM.
• Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc., and related best practices.
• Experience in working with CROs as well as various hands-on DM tasks such as authoring DM plan and other documents, designing CRF, developing and testing clinical databases, annotating CRFs, defining and testing edit checks, reviewing study data, coding AE and medications, generating and resolving DCFs, creating and maintaining project timelines.
• Up to date knowledge of current DM practices and systems. Experience in using Medidata RAVE in the capacity of data manager and sponsor company RAVE administrator required, experience and certification in RAVE study-build preferred.
• Effective oral and written communication skills required.
• Teamwork and interpersonal skills required.
• Highly detail and quality oriented.
• A positive attitude, flexibility and a proactive thought process.
• Must be able to travel domestically and internationally. Domestic and international travel includes spending time at cancer trial sites/institutions, conference centers, offices and hotels.
• Ability to review and present information effectively to internal and external clients, both domestic and international.
• Good working knowledge of medical/scientific terminology and knowledge of ICH guidelines and regulations related to data management activities.
• Solid PC skills including Data Management software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint, and any additional software packages utilized at Taiho.
• The incumbent in this position may be required to perform other duties, as assigned.
  
  

The pay range for this position at commencement of employment is expected to be between $164,000 to $193,000annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, commissions, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.

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