Clinical Data Manager II

Lensa; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Data Manager with 8-10 years of experience in data management. The role involves ensuring effective communication on clinical data metrics, reviewing clinical trial documentation, and adhering to Good Clinical Practices. This position offers competitive compensation and a range of benefits focused on employee well-being.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning offerings

Global Employee Assistance Programme

Flexible optional benefits

Qualifications

• 8-10 years of relevant lead experience.
• Experience with EDC systems is required.
• Oncology and/or inflammatory therapeutic area experience preferred.

Responsibilities

• Participate in multidisciplinary project teams as the primary data management representative.
• Review and develop clinical trial documents and manuals.
• Perform data review and discrepancy resolution.

Skills

Data management

Communication

Quality Control

Education

Bachelor's degree or certification in a related allied health profession

Tools

Electronic Data Capture (EDC) systems

Job description

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Lensa is the leading career site for job seekers at every stage of their career. Our client, ICON Clinical Research, is seeking professionals. Apply via Lensa today!

As a Senior Data Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What You Will Be Doing

Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.

• Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
• Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
• Participate in User Acceptance Testing (UAT), as needed
• Participate in Quality Control (QC), as needed.
• Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
• Assist with site and/or third party vendor training on CDM-related topics.
• Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
• Perform data review and discrepancy resolution, as needed.
• Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
  
  

You Are

(8 -10 years' relevant lead experience)

• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN,
• PA, RT) is preferred, but individuals with commensurate experience will be considered.
• Experience with Electronic Data Capture (EDC) system(s) is required.
• Experience with Oracle Inc.'s Inform EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience (within Data Management) is preferred.
  
  

Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
  
  

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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