Senior Data Management Specialist

20 hours ago

Dublin, Dublin City, Ireland beBeeClinicalDataManagement Full time €72,000 - €104,000
Clinical Data Management Lead

This role offers an exceptional opportunity to lead clinical data management activities for global trials.

Responsibilities
  • Serve as the primary point of contact for customers on data management deliverables.
  • Manage multiple large studies or programs of studies, potentially on a global scale.
  • Provide leadership and senior support to data team leads on multiple large global programs of global studies.
  • Offer project management expertise while working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
  • Lead direct negotiations with customers regarding timelines, finances, processes, and resources.
  • Maintain regular communication with Data Operations team members to ensure milestones meet timelines and quality deliverables are met.
  • Independently oversee DM service delivery with comprehensive DM process and technical expertise in executing projects.
  • Serve as the escalation point for unresolved data issues.
  • Ensure appropriate resources are allocated to meet project deliverables.
  • Create and/or review and sign-off on all data management plan (DMP) documents.
  • Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
  • Act as Subject Matter Expert (SME).
  • Offer leadership and expertise in specific CDM tasks or technologies.
  • Independently manage SOW/budget.
  • Independently contribute to process improvements and solutions for the CDM team/CDM department.
  • Lead a focus team or global/local best practice team.
  • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
Required Skills and Qualifications
  • Previous experience and proven competence in managing the delivery of multiple global trials through the full DM lifecycle (i.e., large trials with at least 1000 patients).
  • Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation).
  • Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently.
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology.
  • Knowledge of operating procedures and work instructions and the ability to apply them in practice.
  • Knowledge of Good Clinical Practices and relevant regulatory guidelines.
  • Excellent communication, interpersonal, customer service, and teamwork skills.
  • Excellent organizational and problem-solving skills.
  • Excellent project management skills.
  • Ability to work independently.
  • Comprehensive understanding of the clinical drug development process.
  • Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Minimum Required Education and Experience
  • Bachelor's Degree, or educational equivalent, in health, clinical, biological, or mathematical sciences, or related field.
  • Around 7 years of direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training, and experience.

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