Data Team Lead

Project Role: Associate Data Team Lead / Data Team Lead
Work Experience: 6 to 12 Years

Work Location / Mode:- Remote / Homebased
Must Have Skills: Clinical data management, Rave, Study lead, End to End Core CDM.

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 Clinical Data Management (CDM) team to provide high
quality data management products that meet customer needs. Provide leadership to the team in the areas
of project planning, execution, and close-out; financial management; 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.
Essential Functions
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 stakeholders. With minimal guidance, support DM service delivery with
comprehensive DM process an
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 deliverable
Qualifications
Bachelor's Degree or educational equivalent, in health, clinical, biological or mathematical sciences, or
related field
a minimum of 3 years direct Data Management experience, including 1 or more years as a CDM project
lead.
r equivalent combination of education, training and experience.
¢ 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 maint