Ionis Pharmaceuticals is seeking a Clinical Data Associate to support the Clinical Data Manager in all aspects of clinical data management throughout study conduct, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements for their RNA-targeted medicines and gene editing therapies.
Requirements
- Proficiency in MS Office including Word, Excel, and PowerPoint required
- 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
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.
Other
- 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.
- 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)
- 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
- Bachelor’s Degree (BA/BS) preferred
- Travel is variable and estimated at 10% domestic and international
