Independently 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, 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 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. 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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