Description
We are seeking a highly experienced Clinical Data Management Lead to independently manage end-to-end delivery of data management services for single/multi-service projects.
The successful candidate will provide comprehensive data management expertise to the Clinical Data Management (CDM) team, ensuring high-quality data management products that meet customer needs.
Key responsibilities include:
- Providing leadership and vision to the team in project planning, execution, and close-out, financial management, communications, and milestone deliverables
- Managing multiple large studies or programs of studies (possibly global)
- Serving as primary point of contact for customers on data management deliverables
- Leading direct negotiations with customers on timelines, financials, processes, and resources
- Ensuring open communications with customers and IQVIA management to independently manage and meet contractual obligations
- Independently managing DM service delivery with comprehensive DM process and technical expertise in executing projects
- Serving as the escalation point for unresolved data issues
- Implementing proactive quality management plans across multiple projects/programs/customer accounts
- Continuously looking for opportunities to improve service
- Developing and working with the team to implement plans to reorganize and drive change (possibly across a customer account)
- Ensuring timely follow-up and resolution of compliance issues
- Serving as a Subject Matter Expert (SME) and providing leadership and expertise in a specific CDM task or technology
- Training and mentoring junior DTL staff in DM expertise
- Coordinating the work of more junior DTL staff
- Independently maintaining internal tracking databases and systems
- Managing SOW/budget, reviewing financial reports monthly, and participating in project reviews as requested
- Identifying out-of-scope tasks and tracking change orders to completion
- Participating in pricing discussions across customer accounts
- Supporting the RFP process (reviewing RFP documents, pricing, attending bid defense)
Requirements:
- Bachelor's degree in Health, Clinical, Biological, or Mathematical Sciences, or a related field
- 7 years of direct Data Management experience, including 5 or more years as a CDM project lead
- Previous experience and proven competence in managing delivery of multiple global trials through the full DM life cycle
- Demonstrated expert data management skills and advanced knowledge of the data management process
- 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
- Comprehensive understanding of the clinical drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers, and customers