Manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs.
communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
Client Management :
Serve as 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
With guidance, provide input for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
Maintain strong customer relationships
Ensure open communications with customer and IQVIA management to manage and meet contractual obligations
Service Management :
Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
With minimal guidance, support DM service delivery with comprehensive DM process and technical expertise in executing projects.
Serve as the escalation point for unresolved data issues
With guidance, work with client data managers, vendors, internal team members for resolution
Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
With guidance, create and / or review and sign-off on all data management plan (DMP) documents
Implement proactive quality management plan. Identify any service and quality issues with agreed upon specifications per the DMP and contract / SOW and work with functional manager(s) to resolve
With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
Identify compliance issues and work with functional manager(s) to ensure timely follow-up and resolution
With guidance, maintain internal tracking databases and systems
Financial Management / Business Development Support :
With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract / Scope of Work (SOW)
Manage SOW / budget
Review financial reports on a monthly basis and participate in project reviews as requested
Identify out of scope tasks and track change orders to completion
With guidance, may serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
With guidance, participate in and support RFP process (review RFP documents, pricing, attend bid defense)
Provide input on DM process improvements or project solutions to CDM team / CDM department
Provide input on the development and implementation of a new technology or tool
Participate in a focus team or global or local best practice team
Perform other duties as directed by functional manager(s)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Previous experience and proven competence in managing study delivery through full DM life-cycle (at least 1 medium Phase III).
Demonstrated data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and / or new technology).
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, e.g., functional managers, senior DTLs.
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.
3 years direct Data Management experience, including 1 or more years as a CDM project lead.
Equivalent combination of education, training and experience.