Clinical Data Manager
Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat diseases with an unmet medical need. We are the pioneer and leader in the discovery and development of antisense drugs. By exploiting various cutting-edge RNA targeting technologies, we are capable of specifically and efficiently targeting any gene of interest, including ones which are not targetable by small molecules or antibodies. We currently have three approved drugs, and a robust pipeline of over 30 drugs in various stages of clinical trials.
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 individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.
CLINICAL DATA MANAGER
The Clinical Data Manager (CDM) is responsible for all aspects of clinical database design and reporting. The CDM executes on policies and procedures for gathering, analyzing, and reporting clinical data for clinical trials that are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Performs/oversees database development and management (e.g., CRF Specifications, Edit Check Specifications, User Acceptance Testing, clean and lock databases)
- Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Manual Review Guidelines)
- Manages and performs 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
- May perform medical coding of data using MedDRA & WHODrug dictionaries
- Evaluates issues, recommend and implement solutions mitigation strategies as required
- Tracks study spending according to established budget and report to department manager
- Assists with vendor selection process for outsourced CDM activities
- Assists, as necessary, with vendor contract negotiation and execution
- Oversees, as necessary, External Service Provider (ESPs) engaged to perform data management and EDC activities
- Assists with regulatory inspection activities
- Assists with oversight of external data providers (e.g., IRT, central and specialty labs, patient diaries)
- Presents at investigator’s meetings and helps lead data management training
- Escalates study related issues and communicates as appropriate with management and other functions
- Represents Clinical Data Management at study team meetings and facilitates cross-functional activities (e.g. Clinical Data Listing Reviews, database lock activities)
- Proactively addresses operational issues and clinical data questions
- Provides updates on study timelines, budget, vendor oversight and other study related activities
- Liaises with the document specialists to ensure data management files are filed appropriately
- Implements best practices and industry standards across all data management activities
- Assists with department initiatives and process improvements
- Performs other duties, as appropriate
- Travel is variable and estimated at 10% domestic and international
COMPETENCIES 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
EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS:
- Bachelor's Degree preferred
- Minimum of one (1) year of direct Clinical Data Management experience
- Experience with Electronic Data Capture (EDC) systems
- Working knowledge of CDISC CDASH and CDISC SDTM standards/guidelines
- Experience/training om the following areas: Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices), 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clincal Trials), HIPAA, Drug Development and Approval Process, Data Management Overview
- Proficiency in MS Office including Word, Excel, and PowerPoint required
- SAS experience preferred but not required
Excellent salary and benefits package offered.
Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition # 18-0201
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.