clinical data manager Carlsbad, CA
Job description
Ionis Pharmaceuticals, Inc., is headquartered in Carlsbad, California, with offices in Boston, Massachusetts, and Dublin, Ireland. For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the undisputed leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
As the first company to fully harness the power of RNA technology for human therapeutics, Ionis’ platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are well positioned financially to deliver on our strategic goals.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together a diverse group of individuals with different skill sets and perspectives into this creative environment to be part of a productive and inclusive team. While acknowledging people are actively engaged in hybrid/remote work, we continue to invest time, money, and energy into making our workplace locations a place where our culture and employees can thrive. We believe engaging on a day-to-day basis, in person, builds solid and lasting relationships, and contributes positively to our culture and innovation. From the heart of our stunning Carlsbad campus, we aim to provide a central connection point for all our employees. These facilities give us the opportunity to connect cross-functionally, collaborate and to build on the success of our business as we continue to grow. Join us and experience our unique culture while you develop and expand your career.
CLINICAL DATA ASSOCIATE
SUMMARY:
The Clinical Data Associate (CDA) is responsible for supporting the Lead Data Manager (LDM) in all aspects of study conduct. The CDA follows standard policies and procedures for supporting the LDM in gathering, analyzing, and reporting clinical data for clinical trials that are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements.
RESPONSIBILITIES:
- Supports the LDM within clinical study team
- Provides cross-study support for data management activities
- As directed by the LDM, 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 LDM, creates various study related documents and plans (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Manual Review Guidelines)
- As directed by the LDM, 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 LDM, 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 LDM
- Supports the LDM 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 LDM
- Supports the LDM with data management documentation filing
- Assists with department initiatives and process improvements
- Travel is variable and estimated at 10% domestic and international
COMPETENCIES IDENTIFIED FOR SUCCESS:
- Excellent analytical and problem-solving skills
- Outstanding 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
- Exceptional attention to detail
- Flexible to changing priorities
- Strong and positive work ethic
REQUIREMENTS:
- Bachelor’s Degree (BA/BS) preferred
- Proficiency in MS Office including Word, Excel, and PowerPoint required
Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition #IONIS003058
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionispharma.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $56,200 to $76,000
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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