Director, Clinical Data Standards
BeiGene
Cambridge
3d ago

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Director, Clinical Data Standards role is responsible for the development, maintenance, and strategy of the BeiGene's global clinical data standards.

This role will report to the Senior Director, Clinical Data Management or higher. This role can be performed remotely, or from any of our offices in the US.

Essential Functions of the job : Responsible for the overall development and strategy of BeiGene’s Global Data Standards Responsible for collaboration with the Clinical Development Team, and function representatives to develop and maintain BeiGene’s global data standards Responsible for broadly communicate global data standards in a way that minimizes data transformations between systems and functions Responsible for developing new global data standards for new therapeutic area when needed Responsible for Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.

Responsible for development and maintenance SOP of global data standards Leads cross-functional Standards initiatives internal or external to BeiGene and helps to ensure coherence of standards initiatives across organization Develops training strategy and ensures consistent training program for standards Conducts periodic review and development of metrics to assess standards utilization and development trends Serves as a resource of Clinical Data Standards to support questions raised by Clinical Development team Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, etc.

Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to BeiGene organization Computer Skills : Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project) Working knowledge of more than three EDC systems, Medidata Rave required SAS Viewer Other Qualifications : 10+ years of experience in Clinical Data Management in the pharmaceutical / biotechnology Proficiency in all areas of Clinical Data Management activities required Excellent experience working in cross-functional team-oriented environments Strong oncology experience required Proven track record for development and management of a standards library Strong communication skills Understanding of ICH and regulatory environment as it pertains to data management Proven experience in internal and external inspection activities required Knowledge of medical and statistical terminology.

  • Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc. Travel : Approximately 4-6 times per year Education Required : Bachelor’s degree or equivalent in a health-related field preferred Competencies : Ethics - Treats people with respect;
  • Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Planning / Organizing - Prioritizes and plans work activities;
  • Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

    Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.

  • Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities;
  • Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.

    Contributes to building a positive team spirit; Shares expertise with others. Adaptability Able to adapt to changes in the work environment.

    Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

  • Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills;
  • Shares expertise with others. Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions;
  • Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance;
  • Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data;
  • Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner;
  • Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget.

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