Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MA, Associate Director, Clinical Data Standards R0011817-MZ


 
 

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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 XXX in our Cambridge office.

OBJECTIVES:

  • Responsible for leading and conducting the development, deployment, management and governance of clinical standards needed to support drug development processes as well as supporting standards initiatives and CROs/strategic service provider interactions.
  • Responsible in an individual contributor role that requires project management leadership of standards projects and the ability to partner closely with internal/external standards stakeholders in a collaborative manner.
  • May be responsible for leading the identification, review/evaluation, deployment and usage of technologies to generate, distribute, integrate with and report on standards compliance internally and collaboratively with CROs/strategic service providers.
  • Builds relationships across the global Takeda organization and with CROs/strategic service providers in support of the standards vision and implementation.
  • Participates with and influences at industry standards forums in support of Takeda s Standards.
  • Serves as a study team resource to support questions raised by regulatory agencies.

ACCOUNTABILITIES:

  • Takes leadership role in standards project implementation.
  • Acts as Standards area project manager for selected standards projects.
  • Establishes and maintains project plans and effectively articulates them; defines risks and recommends contingency plans.
  • Owns, governs and maintains designated GDO developed standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts.
  • Ensures CROs/strategic service providers and Takeda are deploying standards and leveraging them across the organization at an enterprise level.
  • Leads assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards.
  • Conducts standards compliance review and works with functional areas and CROs/strategic service providers to reinforce content and interpretation of Takeda standards.
  • Collaborates closely with CROs/Strategic service providers to ensure appropriate management, training and deployment of Takeda s standards within the service provider s infrastructure.
  • Represents Takeda and Global Development Operations as a member of Standards Development Organization or Standard Support Groups (e.g. CDISC, PhUSE).
  • Leads a Standards Area Working Group/Team.
  • Lead the assessment of applications used for standards metadata management such as the Standards Knowledge Base.
  • Leads the assessment of updates and/or suggested enhancements to the standards library, standards knowledgebase/governance portal, Pinacle21 and other applications. Coordinates with IT where necessary.
  • Contributes to the GDO metadata standards management strategy and leads associated projects or initiatives.
  • Depending on the business need, collaborates with CROs/Strategic service providers and internal key stakeholders to ensure regular non-submission related SDTM deliverables are processed and stored appropriately.
  • Contributes to budget forecasting and resourcing requirements.
  • Reviews proposals and participate in the selection of service/technology providers.
  • Manages contracts and statements of work.
  • Collaborates with Standards Team lead to identify and resolve issues impacting goal attainment. Leads resolution efforts.
  • Contributes to the standards education and training strategy both internal and external. Develops and delivers training programs to affected internal and external staff.
  • Ensures timely communication of new and/or revised standards.
  • Provides timely feedback to user inquiries.
  • Mentors team members, junior staff or contractors via matrix relationships or direct supervision, in standards implementation, optimal usage and by directing work, resolving problems and/or providing guidance
  • May manage contract staff.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • B.S. degree in Scientific or related field is preferred.
  • Minimum 8-10 years in Data Standards or Data Management or Programming or Statistics.
  • Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.
  • Knowledge of XML preferred.
  • Experience with leading teams and/or organizations. Demonstrated knowledge of drug development process.
  • Demonstrated knowledge of regulatory guidances, requirements and industry standard practices as pertaining to clinical data standards and metadata management.
  • Strong attention to detail and accuracy is a must.
  • Ability to read, analyze and interpret complex technical documents and to present complex issues in oral and written form.
  • Ability to think strategically and to develop new approaches and processes.
  • Ability to facilitate discussions and share knowledge across multiple study teams, functional lines and management levels.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Knowledge of at least one data management system and/or working knowledge of SAS.
  • Must have an understanding of database concepts.
  • Strong working knowledge of clinical trial terminology and concepts preferred.
  • Proven ability to manage and communicate effectively with service providers including Budgeting, forecasting, negotiating contracts, reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
  • Demonstrated ability to lead projects and work groups. Strong project management skills.
  • Proven ability to independently and collaboratively resolve problems.
  • 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.
  • Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook
  • Able to influence without authority
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
  • Pragmatic and willing to drive and support change
  • Support a culture of continual improvement and innovation; promote knowledge sharing, etc.

TRAVEL REQUIREMENTS:

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

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-TRL

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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