• Director, Data Management

    Job Locations US-NJ-Princeton
    Category
    R&D Services
    Travel
    25%
    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.

     

     

    The Director, Data Management is a leadership position responsible for providing expertise and leadership of the clinical data management function enabling planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data.  This role will oversee all Clinical Data Management (CDM) preparation to meet corporate goals, budgets, and timelines. This includes but is not limited to vendor qualification/selection, budget planning and contract negotiations, development of corporate data standards, and oversight of all CDM services from study start-up through database lock and study close-out.  The Director , Data Management is a supervisory role and will be accountable for assessment of resource needs both internally and with CRO partners.

    Responsibilities

     

    • Partner with Clinical Development and Biostatistics to ensure the highest quality planning for data collection, data cleaning and data display for all Taiho clinical studies and submission documents.
    • Provide leadership to the Data Management Department, and oversight of data management personnel on Taiho Product Development teams, with a focus on delivering high quality, reliable clinical trial information to support the execution of clinical programs across all phases of development.
    • Accountable for ensuring data is handled consistently from startup through database lock - communicates timelines, resource needs, priorities and other information vital to the efficient conduct of the TOI development programs.
    • Central point of contact for data related deliverables, issues, challenges, risks and mitigations for a program(s) or asset.
    • Lead and develop the data management relationship with preferred DM providers.
    • Keeps current on oncology practices, competitive environment, regulatory or scientific trends, as well as general industry standards and regulatory requirements pertinent to CDM responsibilities.
    • Member of TPC/TOI Global DM standards committee. Collaborates with TPC Data Sciences Department and provides input into the development of global standards and processes including standardized case report forms and CRF instructions, Data Management Plans, and data review documents.
    • Lead CDM standardization initiatives.
    • Responsible for enhancement of CDM infrastructure, capacity and efficiency, especially in Medidata study-build, MedDRA and WHOdrug coding, etc.
    • Mentor and supervise TOI CDM staff. 
    • Responsible for ensuring program budgets associated with TOI clinical study CDM activities are managed within company thresholds.
    • Develop and maintain TOI SOPs pertinent to CDM responsibilities, and collaborate on development of global CDM SOPs.
    • Evaluates DM staff development and training needs; implements training
    • Work with Procurement and Clinical Services on key initiatives related to data monitoring such as Risk Based Monitoring implementation.

     

     

    Qualifications

    Educational Requirements:   

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

    Experience: 

    • Requires a minimum of 8 years progressively increasing related experience with at least 5 years in function/area of specialty preferably oncology.
    • Prior management/supervisory experience in a global setting is required.
    • substantial experience managing staff in global setting
    • Knowledge of oncology research standards and best practice in data collection methodology and operational approaches required.
    • Extensive global clinical trial expertise and a successful track record of leading through influence and working across global organizational environment
    • Experience working in collaboration with CROs
    • Knowledge of FDA and ICH GCP guidelines, standard concepts, practices, and procedures relevant to clinical DM
    • Experience in regulatory GCP inspections/audits
    • Experience with data visualization software
    • Knowledge of standard coding dictionaries MedDRA, WHOdrug, etc and related best practices.
    • Expert knowledge of industry eCRF tools, specifically Medidata RAVE and familiar with industry trends and technologies supporting data collection
    • Cross functional collaboration proficiency with other departments such as Biostatistics, Statistical Programming, Clinical Operations and Pharmacovigilance

    Other Skills and Abilities:

    • Effective oral and written communication skills required.
    • Teamwork and interpersonal skills required.
    • Highly detail and quality oriented.
    • 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.
    • The employee must utilize close vision and be able to adjust focus.

    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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