Job Overview: Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to the Clinical Data Management (CDM) team to deliver high-quality data management products that meet customer needs. Provide leadership in project planning, execution, close-out, financial management, communications, and milestone deliverables. Perform the role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Essential Functions:
- Client Management: Serve as the primary point of contact for customer on data management deliverables. With minimal guidance, 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. Perform direct negotiations with customers regarding timelines, financials, processes, and resources.
- Service Management: Meet with Data Operations Coordinator (DOC) and/or Data Operations team members regularly to ensure milestones meet timelines and quality deliverables. Support DM service delivery with comprehensive DM process and technical expertise in executing projects. Serve as the escalation point for unresolved data issues.
- Financial Management/Business Development Support: Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). Manage SOW/budget. Review financial reports monthly and participate in project reviews as requested. Identify out of scope tasks and track change orders to completion. May serve as Project Manager for single service DM projects.
- Other: Provide input on DM process improvements or project solutions to CDM team/CDM department. Participate in the development and implementation of new technology or tools. Participate in focus teams or global/local best practice teams.
Qualifications:
- Education: Bachelor’s Degree or educational equivalent in health, clinical, biological, or mathematical sciences, or related field.
- Experience: 1-2 years of direct Data Management experience with a minimum of 6 months as a CDM project lead.
- Skills:
- Demonstrated data management skills and thorough knowledge of the data management process.
- 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 applicable regulatory guidelines.
- Excellent communication, interpersonal, customer service, and teamwork skills.
- Excellent organizational and problem-solving skills.
- Excellent project management skills.
- Ability to work with minimal supervision using available resources.
- Comprehensive understanding of the clinical drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
