• Senior Manager, Data Management

    Job Locations US-NJ-Princeton
    Category
    Data Management
    Type
    Regular Full-Time
  • Position Summary

    Taiho Oncology, Inc. works urgently to discover and develop innovative cancer treatments. As cancer evolves, we evolve with it—bringing novel technology to cornerstone chemotherapies, while at the same time optimizing new targeted agents. Advanced technology, dedicated investigators, and incomparable facilities—these vast resources empower us to redefine the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.

     

    This position serves as project management of the Taiho Oncology Inc., (TOI), clinical data management (CDM) activities performed by internal and/or various CRO teams for assigned specific clinical programs. Responsibilities include defining and managing CDM timeline and deliverables, from study start-up to study closeout, overseeing study EDC development, managing CDM activities and deliverables, as well as carrying out hands-on work as a data manager as needed. Responsibilities may also include leading or participating in development of specific Taiho global/TOI CDM processes and/or SOP.

    Responsibilities

    • 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.

    Qualifications

    Educational Requirements:   

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

     

    Experience: 

    • 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.

    Other Skills and Abilities:

    • 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.

    Language Skills:

    • 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.

    Reasoning Ability: 

    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret abstract and concrete concepts.

     

    Computer Skills:

    • 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).

    Physical Demands: 

    • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
    • The employee is occasionally required to walk.

    Work Environment: 

    • The noise level in the work environment is usually quiet.

     

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

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

     

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