Clinical Trial Management Associate

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 TRIAL MANAGEMENT ASSOCIATE

The Clinical Trial Management Associate (CTMA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.

CORE RESPONSIBILITIES

• Conducts study tracking (e.g., CTMS, start-up, milestone, close-out); generates, reviews and distributes management reports from internal tracking systems at requested intervals
• Collaborates with the Clinical Trial Manager and/or the Clinical Project Lead on the development of certain study-specific plans and/or processes
• Presents at team meetings as needed (i.e., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training, etc.)
• Collects and reviews essential documents from Investigational sites
• Supports TMF set-up, maintenance, ongoing quality review, and final reconciliation of study documents
• Participates in study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation
• Contributes to the development of the Monitoring Plan and assists with ensuring appropriate quality and timely monitoring of clinical sites
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Works with internal and external team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high quality trial execution
• Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.)
• Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs)
• Keeps the Clinical Project Lead (CPL) informed of the progress of projects
• Develops and maintains good working relationships with Investigators and study staff
• Assists in the organization and preparation of and participates in Investigator Meetings (as applicable)
• Performs document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Ensures timely study entry and updates to ClinicalTrials.gov
• Assists with design and preparation of study related materials for the training of internal and external staff
• Participates in co-monitoring activities and oversight of CRO or contract CRAs for pre-study, initiation, routine monitoring and closeout visits
• Assists with the tracking and management of study specific budgets
• Participates in development of departmental processes, SOPs, and initiatives
• Assists with facilitating resolution of data queries and requests from Clinical Data Management
• Travel is variable and estimated at 20%

COMPETENCIES IDENTIFIED FOR SUCCESS

• Ability to work in a team or independently as required
• Effective written and verbal communication skills
• Critically evaluates job tasks and the impact on overall trial management objectives
• Sound problem-solving capabilities
• Good judgment in triaging issues from internal and external customers
• Effectively collaborates with Clinical Trial Team members
• Outstanding organizational skills with the ability to multi-task and prioritize
• Exceptional attention to detail
• Proven flexibility and adaptability

EDUCATION, EXPERIENCE, AND OTHER REQUIREMENTS

• Bachelor’s Degree preferred
• Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
• Experience in scientific discipline and multiple therapeutic areas preferred
• Experience/training in the following areas: 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
• Proficiency in MS Office including Word, Excel, and PowerPoint

Please visit our website, www.ionispharma.com for more information about Ionis and to apply for this position; reference requisition # IONIS003101

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 $52,012 to $111,766

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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