Job Overview
Independently manage end-to-end delivery of data management servicesfor 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, Customer Site Manager, 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.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 managerClient Key Responsibilities:
• Lead, establish, execute and maintain a data strategy and reporting oversight plan for the design, collection, processing, transformation, reporting and submission of clinical data across assigned portfolio/studies includes Interventional and Non-Interventional studies.
• Robust oversight of assigned portfolio , represent in CTT or equivalent structure to remain accountable for data driven activities ( e.g protocol review, Database development, GxP relevant document development, SAP and TFL review as needed )
• Provide oversight from collection to publication or equivalent activities for assigned portfolio. Put Data quality plan in place and ensure end to end data quality through data reviews and metrics
• Cost and impact assessment of proposed data collection, analysis and reporting for the TA level therapeutic and disease area programs. Aligns with Data operations and programming head for final review and approvals.
• Drive capability inputs data team’s resource algorithm based on future incoming demands at a TA level.
• Leads or ensures the full spectrum of standard development and compliance across their portfolio if applicable
End-to-End Ownership of the Clinical Data Flow and reporting for all assigned studies across TA:
• Ensure there is end-to-end data flow ownership established for all studies and activities. At the TA level drives consistency in implementation of a lean global data strategy and defines fit for purpose data quality requirements sufficient to support good decision making and meet regulatory requirements.
• Drives consistent and effective collaboration cross-functionally to define quality by design review process to ensure fit for purpose data quality sufficient to support good decision making.
• Drives standards if needed and processes to facilitate data right the first time in line with TA level priorities.
End-to-End Standards Oversight & Lifecycle Management:
• Ensuring compliance with data requirements and the availability of end-to-end clinical data standards (data collection through analysis) for a program/molecule/indication for a given TA if applicable
• Influence and support the design of new clinical data standards as required at the enterprise/ therapeutic area and TA level.
• Ensures consistent vendor data transfer specifications are created and used for all programs and studies at a TA level.
Operational Project and portfolio Management:
• Accountable to ensure consistent data operationalization strategy is developed, communicated, and implemented across all programs and trials of a TA.
• Provide TA level insights to the data product quality, delivery, metrics, status, and issue resolution & escalation.
• Works collaboratively with GMA data operations and programming leadership to define priorities and oversight plan
• Demonstrated ability to manage the TA level deliveries with high impact, working with a cross-functional team in matrix organization.Qualifications
• Bachelor's Life Science Degree preferably with a statistics module. Health, clinical, biological or mathematical sciences, or related field Req
• at least 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. 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.Please note this role is not eligible for the UK visa sponsorship.Please note: due to sponsor requirements for the role only candidates based in the listed location/s will be considered. Any applications from candidates based outside of these locations will not be considered.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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