$150K — $200K *
REMOTE JOB OPPORTUNITY!
Senior Manager, Clinical Data Standards
Director/Associate Director, Clinical Data Solutions
Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.
Clinical Data Solutions (CDS) at Takeda
Key to Takeda's success is the Clinical Data Solutions Team (CDS), providing Strategic planning, resourcing and oversight of clinical trial data deliverables.
CDS engages in strategic partnerships, overseeing expert CROs to ensure successful execution and delivery of Clinical Data. CDS also owns Takeda's strategy for the development and governance of Data Standards, in alignment with the CDISC (Clinical Data Interchange Standards Consortium) industry standards. CDS performs oversight of all Study-level data capture (e.g., EDC, IVR, ePRO, eCOA) technologies and other related vendors and/or applications.
Senior Manager, Clinical Data Standards
The Senior Manager Clinical Data Standards is responsible for the development, deployment, management and governance of clinical standards. They are Takeda's Data Standards Leaders and SMEs, actively engaged in Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into, or enhance Takeda's Clinical Data Standards Library.
The Senior Manager Clinical Data Standards is responsible for leading the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally and collaboratively with CROs/strategic service providers.
The Senior Manager Clinical Data Standards builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and have the ability to partner closely with internal/external standards stakeholders in support of the standards vision and implementation.
* Represents Takeda and Global Development Operations as a member of Standards Development Organization or Standard Support Groups (e.g. CDISC, PhUSE).
* Contributes or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
* Leads or contributes to the development and maintenance of Clinical Data Standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, TFLs and questionnaires). Includes periodic assessment of standards content with respect to compliance and industry impacts.
* May lead the assessment, implementation, integration and governance of systems and tools to support, manage, govern and report on standards
* Leads the development and maintenance of project plans and effectively articulates them; defines risks and recommends contingency plans.
* Leads standards compliance review and works with functional areas and CROs/strategic service providers to reinforce content and interpretation of Takeda standards
* Acts as Standards area project manager or team leader for selected standards projects and teams.
* Develops strategy for Standards Management technology selection and deployment across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models.
* Is accountable for standards delivery life cycle, including deployment strategies, Communications, User training and management.
* Performs other duties as assigned.
* BS/BA required preferably in a health-related, life science area or technology-related fields.
* Proven track record of strong project management skills and experience managing clinical data standards activities for large drug development programs.
* Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management & Data Standards functions.
* Minimum of 8 years data standards and/or drug development process with expertise in the cross-functional interfaces with the data management function.
* Advanced knowledge of office software (Microsoft Office).
* Experience with budget planning & management.
* Strong knowledge of relational databases and experience using multiple clinical data management systems.
* Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
* Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.
* Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology.
* Strong working knowledge of clinical trial terminology and Architect Loader Specification preferred
* Knowledge of XML, ALS and MDR preferred
* Pragmatic and willing to drive and support change.
* Is comfortable with ambiguity.
* 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.
Valid through: 11/5/2021
$80K — $100K *
$140K — $160K *
5 days ago