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Alimentiv

Posted 6 days ago

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Manager, Clinical Data Management

GdanskRemote

AI Summary

Manages the end-to-end delivery of clinical data management services, leading a team to ensure high-quality, timely delivery and regulatory compliance.

About this role

We're looking for a strong people leader to join our Data Sciences Department responsible for end-to-end delivery of data management services, collaborating with internal and external customers and ensuring staff deliver high quality, timely service and meet all regulatory requirements and guidelines. Responsible for meeting operational responsibilities and targets including but not limited to hiring, managing staff performance, utilization, retention, process improvements and financial management for assigned projects.

Operational Management

  • Ensure operational efficiency and excellence by leading and/or assisting in the creation and documentation of new or revised department procedures.
  • Recommend appropriate departmental objectives that support the company strategy and objectives and create solutions to address business and operational challenges.
  • Lead working groups and/or committees to set goals and execute on implementation to address process or procedural gaps.
  • Partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
  • Participate in project and department budget development and responsible for effective management of budgets for assigned projects and staff.
  • Participate in the evaluation and selection of data system vendors to enhance Data Management processes, e.g. EDC, IRT, ePRO, eConsent.
  • Contribute to the financial success of the department and company by effectively managing financial aspects of assigned programs, including but not limited to Work Orders, Change Orders, study forecasting and budgeting.

    • Team Management and Engagement

  • Identify and quantify resource requirements for ongoing and future projects; Interview, hire, onboard and train new staff as appropriate.
  • Supervise, mentor, provide leadership and maintain positive team morale; facilitates conflict resolution.
  • Oversee development of direct reports by setting and tracking individual objectives and key results to support department and company strategies and objectives.
  • Evaluate training needs and conduct performance reviews for assigned staff.
  • Set priorities and oversee activities for assigned staff.

    • Service Delivery Oversight

  • Ensure Data Management deliverables for projects assigned meet/exceed project/study team expectations regarding quality, time, and cost.
  • Serve as the subject matter expert on data collection strategy and handling of study data for assigned programs and effectively liaise with programming to ensure clinical databases are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission.
  • Proactively identify data management project issues, manage risks, and alert Senior Department Management with a view to remedial action.
  • Interact/liaise with other departments to ensure a high level of client satisfaction through successful issue resolution and execution of projects.

    • Other Responsibilities

  • May work with other departments and analysts on special projects to ensure company end to end processes and technologies are efficient and effective, work seamlessly together and deliver improved customer value.
  • May represent Data Management at business development, sponsor, or other professional meetings.
  • Assist the business development team with RFIs, RFPs and project pricing.

    • Qualifications

  • Applicants should have a minimum of a college diploma/degree and 7-9 years of relevant experience. CCDM certification is considered an asset.

    • Skills

    CCDMClinical Data Management (CDM)Data Standards (CDISC)EConsentEDCEPROIRTRegulatory Guidelines (GCP)

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