Ionis Pharmaceuticals, Inc.
Clinical Trial Management Associate
Ionis Pharmaceuticals, Inc., Boston, Massachusetts, us, 02298
Ionis Pharmaceuticals is a pioneer in RNA‑targeted medicines looking to add a Clinical Trial Management Associate (CTMA) to its Study Management Team. The CTMA will support the execution of clinical trials across therapeutic areas and contribute to the successful management of study timelines, documentation and site operations.
Base pay:
$84,240 – $118,308 per year.
Responsibilities
Conduct study tracking (CTMS, start‑up, milestones, close‑out); generate, review, and distribute management reports from internal tracking systems at requested intervals.
Collaborate with the Clinical Trial Manager and/or the Clinical Project Lead on the development of study‑specific plans and processes.
Present at team meetings as needed (e.g., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training).
Collect and review essential documents from investigational sites.
Support TMF set‑up, maintenance, ongoing quality review, and final reconciliation of study documents.
Participate in study specific tasks such as investigator identification, recruitment, collection of investigator regulatory documents and site activation.
Contribute to the development of the Monitoring Plan and assist with ensuring appropriate quality and timely monitoring of clinical sites.
Assist in development of study materials, case report forms (CRFs), informed consent documents for clinical studies.
Work with internal and external team members (Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management, CRO/Vendors) to deliver high‑quality trial execution.
Prepare investigational site reference materials (screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.).
Act as primary contact for study contractors (e.g., contract CTMs, field CRAs).
Keep the Clinical Project Lead informed of project progress.
Develop and maintain good working relationships with investigators and study staff.
Assist in the organization and preparation of investigator meetings (as applicable).
Perform document tracking and signature/approval follow‑up, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation.
Execute meeting logistics (schedule meetings, distribute agendas and minutes), as needed.
Ensure timely study entry and updates to ClinicalTrials.gov.
Assist with design and preparation of study‑related materials for internal and external staff training.
Participate in co‑monitoring activities and oversight of CRO or contract CRAs for pre‑study, initiation, routine monitoring, and close‑out visits.
Assist with tracking and management of study‑specific budgets.
Participate in the development of departmental processes, SOPs, and initiatives.
Assist 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.
Critical evaluation of job tasks and the impact on overall trial management objectives.
Sound problem‑solving capabilities.
Good judgment in triaging issues from internal and external customers.
Effective collaboration 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 a healthcare‑related industry, or equivalent combination of education and experience; site monitoring experience is a plus.
Experience in scientific disciplines and multiple therapeutic areas preferred.
Experience/training in GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Electronic Records/Signatures), HIPAA, Drug Development and Approval Process.
Proficiency in MS Office (Word, Excel, PowerPoint).
Benefits: Ionis offers an excellent benefits package! Follow this link for more details: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
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Base pay:
$84,240 – $118,308 per year.
Responsibilities
Conduct study tracking (CTMS, start‑up, milestones, close‑out); generate, review, and distribute management reports from internal tracking systems at requested intervals.
Collaborate with the Clinical Trial Manager and/or the Clinical Project Lead on the development of study‑specific plans and processes.
Present at team meetings as needed (e.g., Clinical Trial Team Meeting, Project Team Meeting, Investigator Meeting, project training).
Collect and review essential documents from investigational sites.
Support TMF set‑up, maintenance, ongoing quality review, and final reconciliation of study documents.
Participate in study specific tasks such as investigator identification, recruitment, collection of investigator regulatory documents and site activation.
Contribute to the development of the Monitoring Plan and assist with ensuring appropriate quality and timely monitoring of clinical sites.
Assist in development of study materials, case report forms (CRFs), informed consent documents for clinical studies.
Work with internal and external team members (Clinical Supplies, Toxicology PK, Regulatory Affairs, Clinical Data Management, CRO/Vendors) to deliver high‑quality trial execution.
Prepare investigational site reference materials (screening/enrollment logs, Delegation of Site Responsibilities form, Site Monitoring Log, etc.).
Act as primary contact for study contractors (e.g., contract CTMs, field CRAs).
Keep the Clinical Project Lead informed of project progress.
Develop and maintain good working relationships with investigators and study staff.
Assist in the organization and preparation of investigator meetings (as applicable).
Perform document tracking and signature/approval follow‑up, including Confidential Disclosure Agreements (CDAs), contracts, proposals, invoices, and other study documentation.
Execute meeting logistics (schedule meetings, distribute agendas and minutes), as needed.
Ensure timely study entry and updates to ClinicalTrials.gov.
Assist with design and preparation of study‑related materials for internal and external staff training.
Participate in co‑monitoring activities and oversight of CRO or contract CRAs for pre‑study, initiation, routine monitoring, and close‑out visits.
Assist with tracking and management of study‑specific budgets.
Participate in the development of departmental processes, SOPs, and initiatives.
Assist 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.
Critical evaluation of job tasks and the impact on overall trial management objectives.
Sound problem‑solving capabilities.
Good judgment in triaging issues from internal and external customers.
Effective collaboration 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 a healthcare‑related industry, or equivalent combination of education and experience; site monitoring experience is a plus.
Experience in scientific disciplines and multiple therapeutic areas preferred.
Experience/training in GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Electronic Records/Signatures), HIPAA, Drug Development and Approval Process.
Proficiency in MS Office (Word, Excel, PowerPoint).
Benefits: Ionis offers an excellent benefits package! Follow this link for more details: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
#J-18808-Ljbffr