Data Team Lead
IQVIA
Bengaluru, KA, India
10h ago
source : CareerArc Group LLC

PURPOSE

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.

    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 Quintiles 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)

    Other :

    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 coworkers, managers and customers

    Qualifications

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 3 years direct Data Management experience, including 1 or more years as a CDM project lead;
  • or equivalent combination of education, training and experience

    PHYSICAL REQUIREMENTS

    Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    Extensive use of keyboard requiring repetitive motion of fingers

    Regular sitting for extended periods of time

    Occasional travel is required

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