Jobs at IQVIA

Essential Functions

• Client Management: Serve as primary point of contact for customer on data management deliverables
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies Provide leadership and senior support to DTLs on multiple large global studies/programme of global studies.
• 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
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships
• Ensure open communications with customer and IQVIA management to independently 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
• Provide training and development on data management expertise to junior team members
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues
• Independently work with client data managers, vendors, internal team members for resolution
• 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/programmes/customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
• Continuously look for opportunities to improve service
• Develop and work with team to implement plan to re-organise and drive change (possibly across a customer account)
• 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
• Serve as customer site lead for one or more customers
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff
• Independently maintain internal tracking databases and systems
• Financial Management/Business Development Support:
• Independently 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
• Participate in pricing discussions across customer account
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
• Independently support RFP process (review RFP documents, pricing, attend bid defense) Other:
• Independently bring process improvements and solutions to the CDM team/CDM department
• Lead a focus team or global or local best practice team
• Communicate lessons learned and/or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool
• Present at professional conferences and/or publish articles in professional journals
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
• Perform other duties as directed by the functional manager

Qualifications

• Bachelor's Degree Health, clinical, biological or mathematical sciences, or related field Req
• 5 years of direct Data Management experience with 3 or more years as a CDM project lead Pref
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced 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 and proven competence in handling complex customer negotiations and bid defense meetings independently.
• 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 organizational and problem-solving skills. Excellent project management skills.
• Ability to work independently. Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.

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Essential Functions

• Gather Study Set up requirements through discussion and communication with relevant stakeholders.
• With Minimal guidance - support, overview of validation of new Device integrations.
• Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
• Ensure that all the deliverables are of expected quality standards and meet customer expectations.
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
• Support Training of New joiners.
• Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
• Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required.
• With Guidance manage & oversight the implementation of new technology / database revisions.
• Work closely with the programming team for process innovation and automation.
• Be compliant to trainings and eSOP reading.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
• Communication with Line Manager, and other team members across functions should be collaborative.
• Perform other duties as directed by Line Manager.

Qualifications

• Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
• 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
• English Fluency Spoken and English Advanced
• Advanced computer applications like Microsoft excel, word, Inbox etc
• Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced