Clinical Data Management Lead, home-based

RESPONSIBILITIES

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global).
• Provide leadership and senior support to 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 customer, 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.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• 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.