Clinical Data Science Lead

Icon • Remote, OR

392d

About The Position

The Clinical Data Manager (CDM) will perform complex scientific clinical data reviews in collaboration with Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS). This role involves ensuring adherence to applicable SOPs, WIs, and regulatory requirements while providing scientific data review support for clinical trials of varying complexity. The CDM will engage in data management activities from protocol design through to data collection, ensuring quality and timely delivery of clinical data management milestones.

Requirements

• BS/BA degree or higher in Health Sciences or related field.
• Data Management experience, preferably including clinical data review.
• Knowledge of medical terminology is preferable.
• Experience in clinical drug development within the pharmaceutical industry or related industry.
• Collaboration experience with clinical teams.

Nice To Haves

• Significant experience with clinical data review.
• Experience in a related industry.

Responsibilities

• Perform scientific clinical data review in collaboration with SRP and SRS.
• Adhere to applicable SOPs, WIs, policies, and regulatory requirements.
• Provide scientific data review support for multiple low to moderate complexity trials or one high complexity trial.
• Collaborate with the study team on data management activities for complex indications and therapy-related elements.
• Review data flows and Data Management Plans, performing continuous data review activities.
• Provide input into study-specific data collection tools during protocol design.
• Manage CDM and SRS/SRP related queries in the eDC system.
• Lead and attend meetings to establish and confirm data review expectations for assigned trials.
• Review content and integration requirements for eCRF and other data collection tools.
• Set timelines and follow up to ensure delivery of Clinical Data Management milestones.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits including childcare vouchers and discounted gym memberships.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree