Clinical Trial Management Associate

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 reputed company in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and reputed company 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 reputed company to advancing new approaches in gene editing to reputed company greater value to patients and are reputed company 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 reputed company. We know that our reputed company is a reputed company result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of reputed company health, we look to add diverse individuals, reputed company sets and perspectives to our exceptional team. We continue to invest time, reputed company and energy into making our onsite, hybrid and remote work environments a reputed company where solid and lasting relationships are reputed company and where our culture and employees can reputed company. We’re building on our rich history, and we reputed company our greatest achievements are reputed company of us. If you’re passionate about reputed company to have meaningful reputed company on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you reputed company and expand your career! CLINICAL TRIAL MANAGEMENT ASSOCIATE (CTMA) reputed company 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.

Responsibilities

• Conducts study tracking (e.g., CTMS, start-up, reputed company, reputed company-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 reputed company 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 reputed company 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 reputed company and reputed company monitoring of clinical sites
• Assists in development of study materials, case report forms (CRFs), informed consent documents for clinical studies
• Works with reputed company team members (i.e. Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management and CRO/Vendors) to deliver high reputed company trial execution
• Prepares investigational site reference materials (i.e., screening/enrollment logs, Delegation of Site Responsibilities reputed company, Site Monitoring Log, etc.)
• Acts as primary contact for study contractors (e.g., contract CTMs, field CRAs)
• Keeps the Clinical Project reputed company (CPL) informed of the reputed company of reputed company
• 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), reputed company, proposals, invoices, and other study documentation
• Executes meeting logistics (e.g., schedule meetings, distribute meeting agendas and minutes), as needed
• Ensures reputed company study entry and updates to ClinicalTrials.gov
• Assists with design and preparation of study reputed company materials for the training of reputed company staff
• Participates in co-monitoring activities and reputed company of CRO or contract CRAs for reputed company-study, initiation, routine monitoring, and closeout reputed company
• Assists with the tracking and management of study specific budgets
• Participates in development of departmental processes, SOPs, and initiatives
• Assists with facilitating reputed company of data queries and requests from Clinical Data Management
• Travel is variable and estimated at 20%

Competencies Identified For reputed company

• Ability to work in reputed company or independently as required
• Effective written and verbal communication skills
• Critically evaluates job tasks and the reputed company on overall trial management objectives
• reputed company problem-solving capabilities
• Good judgment in triaging issues from reputed company 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

Requirements

• Bachelor’s Degree preferred
• Minimum of two (2) years in clinical research or reputed company reputed company 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 reputed company Practices, 21 CFR Part 11 and Computer reputed company (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, reputed company, and PowerPoint

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004035 Ionis offers an excellent benefits package! Follow this reputed company for more details: Ionis Benefits Full Benefits reputed company: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits The pay reputed company for this position is $88,776 to $133,156 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. reputed company. and reputed company its subsidiaries are proud to be EEO reputed company. Apply tot his job Apply To this Job