IQVIA
Clinical Data Management Lead
Clinical Data Management Lead
Posted yesterday
ReadingPermanentRemoteFull-TimeLead
Posted yesterday
Description
RESPONSIBILITIES
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
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.
- 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 programs 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
- Meet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
- Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
- Serve as the escalation point for unresolved data issues
- Ensure appropriate resources are assigned to meet project deliverables
- Create and/or review and sign-off on all data management plan (DMP) documents
- Manage service performance and provide leadership to identify root causes of issues and implement remedial actions
- Serve as Subject Matter Expert (SME)
- Provide leadership and expertise in a specific CDM task or technology
- Independently manage SOW/budget
- Independently bring process improvements and solutions to the CDM team/CDM department
- Lead a focus team or global or local best practice team
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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)
- 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 co-workers, managers and customers
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field
- Around 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
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.
IQVIA
Global leader in life sciences analytics, clinical research, and healthcare intelligence
DurhamContract Research1000+
IQVIA
Shape the future of healthcare by solving problems that matter. Work with cutting edge AI and vast clinical data to accelerate treatments. Collaborate across 100 countries on projects that directly improve patient outcomes and save lives.