Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Boston

Description

Job Description


Head Clinical Data Solutions

Department:

R+D/ Global Development Operations- Development Support

Location:

Boston

Responsible for:


- Data collection/extraction strategy and alignment with clinical protocol / industry data standards. Including oversight of CRO-led implemention, execution and delivery of clinical data
- Lead and organize the Global Development Operations technology systems strategy, in collaboration with preferred vendors, therapeutic area units and IT, to support the timely and efficient delivery of global development programs with high quality and within allocated budget.
- Develops, implements and oversees an operational data ownership strategy in support of global development projects and marketed products for all Takeda therapeutic areas.
- Drives strategy to ensure compliance to CDISC standards for all development programs and marketed products to ensure regulatory submission compliance.
- Provide insight on latest technologies and changes in regulatory environments, enabling proactive approach and planning to meet future requirements and efficient study and data management support of global development programs.
- For Therapeutic Area and Phase IV / registry programs overall responsibility for:Strategic planning, resourcing, oversight of data deliverables including design and implementation of data capture tools, data processing, coding, validation, data qualityArchival and inspection readiness of data management TMF documentsVendor oversightData management representation on clinical subteamEnsures the vendor’s technology processes meet or exceed the regulatory requirements to support Takeda’s global development projects, marketed products, Vaccine Business unit and Local Operating Companies (LOCs).Partners with preferred vendors and Takeda functional areas such as Quantitative Science, CMCC and IT to drive technology improvement and innovation to enhance data capture and clinical trial management efficiency and data quality.Responsible for planning and management of external budgets related to data technology licensing, hosting and deliverables.Collaborates with Quality Assurance to set Takeda strategy for audits and assessments of vendor clinical trial collection systems for compliance with regulatory requirements and principles of the software development life cycle.
- For Data Standards overall responsibility forData standards development and adherence including:Guidance on data continuumData standards libraryGovernanceTrainingTechnical servicesCRO oversight CDUSC standards strategy to ensure Takeda submissions will be in compliance with regulatory expectationsClin Inform Ops, including:Technical oversight at study level of data capture (e.g., IVR, ePRO, etc) and other technologiesSupport of CTMS (or equivalent system) of key op data, quality
- Auxiliary data tools (ePRO, Endpoints, etc.) CORE ELEMENTS :


- Develops, implements and oversees an operational data ownership strategy in support of global development projects and marketed products for all Takeda therapeutic areas.
- Drives strategy to ensure compliance to CDISC standards for all development programs and marketed products to ensure regulatory submission compliance REQUIREMENTS:


- BS degree in Computer Science, Life Science or other technical field required; advanced degree desired.
- 10+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
- 8+ years of project management and leadership experience
- Knowledge of general database programming and computing principles, common software products and technologies used in drug development
- Ability to develop and evaluate business cases and effectively manage budgets
- Good knowledge of FDA and ICH regulations and industry standards applicable to drug development systems
- Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy.
- Senior management experience in Clinical Data Management or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
- Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
- Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry Locations


Boston, MA

Worker Type


Employee

Worker Sub-Type


Regular

Time Type


Full time

Job ID R0016426

About the company

NeuvooBulkUS

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