Clinical Data Associate - Clinical Data Science

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

CLINICAL DATA ASSOCIATE - CLINCAL DATA SCIENCE

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.

CORE 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

COMPETENCIES IDENTIFIED FOR SUCCESS

• 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

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS

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

Please visit our website, www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003206

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=to%20Applicants%C2%A0%C2%BB-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $67,602 to $81,411

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.