Clinical Trial Management Associate
AKCEA Therapeutics4.0
Carlsbad, CA
Job description

For more than 30 years, Ionis Pharmaceuticals has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. Scientific innovation began and continues at Ionis with the understanding that sick people depend on us.

As the first company to fully harness the power of RNA technology for human therapeutics, our platform continues to revolutionize drug discovery and transform the lives of patients with unmet needs. Our medicines span multiple therapeutic areas, routes of administration and diverse patient populations. Ionis innovation is driving meaningful progress for many of the most challenging health issues.

We are building upon our innovative research and drug development excellence to provide greater value to patients. Based on the breadth and remarkable progress of our pipeline, Ionis is projecting to have a vast number of new transformational products on the market in the coming years and growing our commercial capabilities. 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 workforce, comprised of individuals from different backgrounds and with unique skill sets, into our creative and productive environment. Join us and experience our unique culture while you develop and expand your career.

CLINICAL TRIAL MANAGEMENT ASSOCIATE

The Clinical Trial Management Associate (CTMA) is part of the Study Management Team that is responsible for successful management and execution of clinical trials. This position is an in-house position, with minimal travel associated with co-monitoring activities.

CORE RESPONSIBILITIES:

  • 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
  • Performs 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 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
  • 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 meetin gs, distribute meeting agendas and minutes), as needed
  • May assist with 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 field CRAs for pre-study, initiation, routine monitoring and closeout visits
  • Assists with oversight of study vendors
  • Helps facilitate resolution of data queries and requests from Clinical Data Management
  • Assists with the tracking and management of study specific budgets
  • Participates in development of departmental processes, SOPs, and initiatives
  • Travel is variable and estimated at 20%

COMPETENCIES IDENTIFIED FOR SUCCESS:

  • Ability to work in a team or independently
  • Effective written and verbal communication skills
  • Able to critically evaluate 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), HIPAA, Drug Development and Approval Process
  • Proficiency in MS Office including Word, Excel, and PowerPoint


Excellent salary and benefits package offered.

For more information about Ionis and to apply for this position, please visit our website, www.ionispharma.com. Reference Requisition #IONIS002965

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

#LI-JB1 #LI-Remote #LI-Hybrid #LI-Onsite

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Company details

Employee

11 to 50

Revenue

$1M to $5M (USD)

Company Description
Akcea Therapeutics, Inc, is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.
Company ratings
  • Overall
    4.0
  • Company & Benefits
    4.5 / 5
  • Culture & Values
    4.0 / 5
  • Career Opportunities
    4.0 / 5
  • Work/Life Balance
    4.0 / 5
  • Senior Management
    4.0 / 5
Company reviews
"Excellent organization, leadership very thoughtful and fully engaged."
Former EmployeeController
Leadership by example is easily observed within the organization and the sense of common ownership is very high and is not surprising to see how dedicated the entire workforce is. The team work hard and play hard when appropriate.

"Great Company"
Current EmployeeTerritory Manager
Treats employees great. Great Company. Challenging rare diseases. Fantastic Culture. Passionate Leadership. Focused attention to help patients in need.

"Great culture and company"
Current EmployeeFinancial Consultant
commitment to patients and employees collaborative culture opportunities to learn and advance ability to work remotely and off & on work hours to work within your schedule