Data Team Lead
QuintilesIMS
IND-Karnataka-Bangalore
24d ago

PURPOSE

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.

  • Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management;
  • communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and / or a leadership role in a specific CDM task (e.

    g. Subject Matter Expert (SME). 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

    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

    Provide justification 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

    Support DM service delivery with comprehensive DM process and technical expertise in executing projects

    Serve as the escalation point for unresolved data issues; 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

    Create and / or review and sign-off on all data management plan (DMP) documents

    Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW

    Implement proactive quality management plans across multiple projects / programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions

    Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects / programme (with minimal support)

    Ensure timely follow-up and resolution of compliance issues

    Serve as Subject Matter Expert (SME)

  • Provide leadership and expertise in a specific CDM task or technology
  • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff

    Maintain internal tracking databases and systems

    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 on a monthly basis and participate in project reviews as requested
  • Identify out of scope tasks and track change orders to completion
  • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing

    Participate in and support RFP process (review RFP documents, pricing, attend bid defense)

    Other :

    Independently bring solutions to the CDM team / CDM department

    Lead and / or participate in a focus team or global or local best practice team

    Communicate lessons learned and / or present in CDM workshop(s)

    Participate in the development and implementation of new technology or tool

    Present at professional conferences and / or publish articles in professional journals

    Provide review and input on developing, revising, and maintaining core operating procedures and work instructions

    Perform other duties as directed by the functional manager

    REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

    Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies / programmes)

    Demonstrated expert 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)

    Previous experience of handling customer negotiations

    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 project management skills

    Excellent organizational and problem-solving skills

    Ability to work independently with 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 5 years direct Data Management experience, including 3 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

    Did You Know?

    We know that meaningful results require not only the right approach but also the right people . Regardless of your role, we invite you to reimagine healthcare with us.

    You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

    Whatever your career goals, we are here to ensure you get there!

    We invite you to join IQVIA™.

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