Senior Data Team Lead, FSP

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
• Working hours to accommodate global client and projects

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelors 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

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