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Dir Clinical Data Solutions- Oncology at Millennium Pharma, Inc. in Boston, Massachusetts

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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Job Description

Job Title:

Dir Clinical Data Solutions

Reports To (Title):

Vice President, Global Clinical Data Management & Technology

Function:

Global Development Support

Department:

Clinical Data Management & Technology

OBJECTIVES (optional): 


  • Responsible for ensuring timeliness and high quality for all Data Management (DM) deliverables globally within a key therapeutic area.  Provides oversight of DM budget in collaboration with program management.

  •  Provides data management expertise and capability in support of global development programs as well as post-marketing registration and non-registration studies.

  • Responsible for oversight of data management strategic vendor partnerships in order to maximize effectiveness and efficiency of external (CRO) resources.

  • Benchmarks industry best practices and changes in Data Management process, outsourcing strategies and DM vendor management.



ACCOUNTABILITIES: 

  • Responsible for all vendor oversight activities across all global development programs within a key

    therapeutic area for Takeda.  Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.


  • Sets strategy and leads functional governance with Takeda’s strategic suppliers.  Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.

  • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and  Statistics:

    • Design and implementation of data capture tools

    • Data processing, coding and validation

    • Responsible for the quality of the data in each database, as well as quality of other data management deliverables  



  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents

  • Responsible for forecasting future outsourcing needs, assessing vendor capacity against assigned work and aligning vendor strategy with these factors.

  • Oversees the planning and management of external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. 

  • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.

  • Identifies, recommends and drives changes in industry best practices and/or regulatory trends

  • Other duties as assigned



Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS:


  • BS degree in analytical or health-related field (MS preferred).

  • 10+ years of data management experience in the pharmaceutical industry

  • Expert knowledge and successful experience managing vendor relationships and alliance partnerships with at least 7 years experience in this area

  • 5+ years of line management experience (prior second-level management experience preferred).

  • Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

  • Experience with budget planning

  • Strong knowledge of relational databases and experience using multiple clinical data management systems

  • Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.

  • Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.



Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time