Description
We are seeking an experienced Clinical Data Manager to serve as primary point of contact for customers on data management deliverables.
Responsibilities:
- Manage multiple large studies or programs of studies (possibly global)
- Provide leadership and senior support to Data Team Leads (DTLs) on multiple large global programs of global studies
- Provide project management expertise 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, e.g., timelines, financial, process, resources
- Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
- Independently manage 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 assigned 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
- Serve as Subject Matter Expert (SME)
- Provide leadership and expertise in a specific CDM task or technology
- Independently manage SOW/budget
- Independently bring process improvements and solutions to the CDM team/CDM department
- Lead a focus team or global or local best practice team
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
Requirements:
- Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e., large trials of 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 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 direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training, and experience