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 are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we 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 our success is a direct result of the exceptional talent 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 and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us.  We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.  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 (CCDM) 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 # IONIS00####

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 Applicants »-,Benefits,-Employees are rewarded

The pay scale for this position is $66,726 to $80,782
 

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

Salary : $66,726 - $80,782