Associate Director, Clinical Data Standards
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Associate Director, Clinical Data StandardsApply Now
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.
- 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.
- 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.
- 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.
Job ID R0011817