Manager, Clinical Data Standards
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Manager, 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 Manager, Clinical Data Standards 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.
- May contribute to budget forecasting and resourcing requirements.
- Reviews proposals and participate in the selection of service/technology providers.
- May manage 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.
- May mentor 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 5- 7years 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
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to sit and stand for long periods of time.
- Carrying, handling and reaching for objects.
- Manual dexterity to operate office equipment i.e. computers, phones, 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 R0011818