Clinical Data Associate - Clinical Data Science

Ionis Pharmaceuticals • Carlsbad, CA

70d • $67,602 - $81,411 • Hybrid

About The Position

The Clinical Data Associate (CDA) is responsible for supporting the Clinical Data Manager (CDM) in all aspects of clinical data management throughout study conduct. The CDA follows standard policies and procedures for supporting the CCDM in gathering, analyzing, and reporting clinical data for clinical trials that are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements.

Requirements

• Bachelor's Degree (BA/BS) preferred
• Proficiency in MS Office including Word, Excel, and PowerPoint required

Nice To Haves

• Excellent analytical and problem-solving skills
• Excellent organizational and time-management skills with ability to multitask and prioritize
• Strong interpersonal and communication skills
• Ability to effectively develop and manage relationships with internal and external stakeholders
• Excellent attention to detail
• Flexible to changing priorities
• Strong and positive work ethic

Responsibilities

• Supports the CDM within clinical study team
• Provides cross-study support for data management activities
• As directed by the CDM, supports database development and data management activities (e.g., CRF Specifications, Edit Check Specifications, User Acceptance Testing, data cleaning, database locks)
• As directed by the CDM, support the adoption of Clinical Data Warehouse technology to enable streamlined CDM data review
• As directed by the CDM, creates various study related documents and plans (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Data Review Plan)
• As directed by the CDM, support with programming specifications, requests, and QC.
• As directed by the CDM, supports ongoing data management activities including CRF review, query generation, receipt and reconciliation of external data, SAE reconciliation, data listing generation and production of CDM summary reports within projected study timelines.
• As directed by the CDM, performs medical coding of data using MedDRA & WHODrug dictionaries
• May attend study specific investigators' meetings and other data management trainings
• Escalates study related issues to the CDM
• Supports the CDM to prepare for study team meetings and complete cross-functional activities (e.g. study metrics, clinical data listing reviews, database lock activities)
• Proactively identifies and raises operational issues and clinical data questions to CDM
• Supports the CDM with data management documentation filing
• May support regulatory inspection activities with supervision
• Travel is variable and estimated at 10% domestic and international

Benefits

• Comprehensive health insurance
• 401k plan
• Paid time off
• Flexible work environment
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees