Jobbörse

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!

The Senior Clinical Data Manager is responsible for all aspects of clinical data management throughout study conduct. The Senior Clinical Data Manager 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.

Responsibilities:

• Acts as lead data manager within study team
• Performs/oversees database development and management (e.g., CRF Specifications, Edit Check Specifications, Programming Specifications and QC, User Acceptance Testing, open, clean and lock of databases)
• Support the adoption and implementation of Clinical Data Warehouse technology to enable streamlined CDM data review strategies
• Implement Risk Management Planning on clinical studies
• 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 (e.g. metrics) within projected study timelines.
• Performs medical coding of data using MedDRA & WHODrug dictionaries
• Ensures clinical data management activities are executed in compliance with regulatory authority requirements and Good Clinical Practices (GCP)
• Evaluates issues, recommend and implement solutions mitigation strategies as required
• Assists or leads with vendor selection process for outsourced CDM activities
• Oversees, as necessary, multiple External Service Provider (ESPs), contractors, or direct reports engaged to perform data management and EDC activities
• Participates in governance of External Service Provider (ESPs) across studies
• Participates in training of new hires and/or junior team members
• Supports regulatory inspection activities
• Oversees external data providers (e.g., IRT, central and specialty labs, patient diaries)
• Presents at investigator's meetings and other data management trainings for study
• 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, 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 and leads department initiatives, process improvements, and cross functional initiatives
• Performs other duties, as appropriate
• Travel is variable and estimated at 10-20% domestic and international

Competencies:

• 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

Requirements:

• Bachelor's Degree (BA/BS) preferred
• Minimum of five (5) years of direct Clinical Data Management experience, including at least 2 years of Study Lead Data Manager responsibilities.
• Experience with Electronic Data Capture (EDC) systems
• Working knowledge of CDISC CDASH and CDISC SDTM standards/guidelines
• Experience/training in 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 Clinical Trials), HIPAA, Drug Development and Approval Process, Data Management Overview
• Proficiency in MS Office including Word, Excel, and PowerPoint required
• Medical coding experience preferred but not required