Clinical Data Management Lead

namename·Remote(United States)
Healthcare
Excel

WFA Digital Insight

The demand for skilled clinical data management professionals has grown significantly, with a 25% increase in job postings over the past year. As the life sciences industry continues to evolve, companies like IQVIA are looking for experts who can oversee complex clinical trials and ensure regulatory compliance. With over 10 years of experience in clinical data management required, this role is ideal for seasoned professionals looking to lead cross-functional teams and drive process improvements. Before applying, candidates should be aware of the importance of strong leadership and communication skills, as well as expertise in tools like Medidata Rave and Oracle InForm.

Job Description

About the Role

The Clinical Data Management Lead role is a critical position at IQVIA, responsible for overseeing the end-to-end data management delivery for global clinical trials. As a seasoned professional in this field, you will lead cross-functional teams, ensure quality and accuracy, and drive process improvements to bring new therapies to life. This is a remote, full-time position with all necessary equipment provided, allowing you to work from the comfort of your own home.

The role entails managing complex, global clinical trials from study setup to database lock, serving as the main client contact for all data management deliverables, and overseeing SAE, PK, and external data reconciliation and database deployment. You will also be responsible for managing timelines, budgets, and resource allocation to meet customer expectations.

As a leader in this field, you will have the opportunity to mentor junior data management staff, promote best practices, and drive regulatory and SOP compliance. Your expertise and experience will be invaluable in helping IQVIA achieve its goals and bring new treatments to market.

What You Will Do

  • Lead data management for complex, global clinical trials from study setup to database lock
  • Serve as the main client contact for all data management deliverables
  • Oversee SAE, PK, and external data reconciliation and database deployment
  • Manage timelines, budgets, and resource allocation to meet customer expectations
  • Mentor junior data management staff and promote best practices
  • Drive process improvements and ensure regulatory and SOP compliance
  • Utilize Excel and other tools to analyze and manage data
  • Collaborate with cross-functional teams to ensure successful trial outcomes
  • Develop and implement data management plans and strategies
  • Ensure quality and accuracy of data and reports

What We Are Looking For

  • Bachelor's degree in life sciences, health, clinical, biological, or mathematical field
  • At least 10 years of direct clinical data management experience, with 5+ years in a Lead Clinical Data Management role
  • Proven success managing large global studies (1000+ patients)
  • Expertise with Medidata Rave, Oracle InForm, or similar EDC systems
  • Strong understanding of GCP, ICH, and clinical research processes
  • Excellent communication and leadership skills
  • Ability to work remotely and manage a team
  • Strong problem-solving and analytical skills
  • Experience with data management tools and software
  • Certification in clinical data management or a related field

Nice to Have

  • Experience with machine learning or artificial intelligence
  • Knowledge of programming languages such as Python or R
  • Familiarity with data visualization tools
  • Experience with cloud-based data management systems
  • Certification in a related field, such as project management or quality assurance

Benefits and Perks

  • Fully remote role with company-provided equipment
  • Competitive salary and performance-based incentives
  • Career growth and learning opportunities through mentoring and internal mobility
  • Inclusive, global culture focused on innovation and collaboration
  • Access to cutting-edge technology and tools
  • Opportunities for professional development and advancement
  • Comprehensive benefits package, including health, dental, and vision insurance
  • Retirement savings plan with company match
  • Paid time off and holidays
  • Remote stipend and home office setup support

How to Stand Out

  • Make sure to highlight your experience with clinical data management tools and software, such as Medidata Rave and Oracle InForm.
  • Emphasize your leadership and communication skills, as well as your ability to work remotely and manage a team.
  • Be prepared to discuss your experience with GCP, ICH, and clinical research processes, and how you have applied these in previous roles.
  • Showcase your problem-solving and analytical skills, and provide examples of how you have driven process improvements in previous roles.
  • Consider obtaining certification in clinical data management or a related field to demonstrate your expertise and commitment to the field.
  • Research IQVIA and its culture to understand the company's values and mission, and be prepared to discuss how your skills and experience align with these.
  • Prepare examples of your experience managing large global studies and ensuring regulatory and SOP compliance.

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