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Clinical Affairs Specialist at Haemonetics - ApplyBlast

Clinical Affairs Specialist

Haemonetics

3 months ago

3.3 on Glassdoor

Massachusetts, United States

Hybrid

Full Time

Senior

1 applicant

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About this role

The Clinical Affairs Specialist supports the execution of clinical studies for product development, regulatory submissions, and post-market needs at Haemonetics. This role ensures study activities comply with regulatory requirements and company SOPs while collaborating cross-functionally with internal teams, vendors, and research sites. The position involves managing study timelines, documentation, data review, and issue resolution to generate high-quality clinical evidence.

Responsibilities

Support day-to-day activities for company-sponsored clinical studies from planning through close-out
Maintain study documentation including TMF and draft key clinical documents like ICFs and CRFs
Collaborate with internal stakeholders, CROs, and vendors to ensure protocol compliance
Support data review, cleaning, query follow-up, and issue resolution activities
Contribute to clinical sections of regulatory submissions such as IDE, PMA, and 510(k)

Skills

Qualifications

Bachelor's degree in life sciences or related field2+ years of experience in clinical affairs or clinical researchUnderstanding of GCP and ICH guidelinesExperience working with CROs and clinical sites

About Haemonetics

haemonetics.com

Headquarters

Boston, Massachusetts, United States

Company Size

1001-5000 employees

Founded

1971

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Haemonetics provides a suite of innovative medical technology solutions that improve the quality, effectiveness and efficiency of care. We challenge ourselves to think big and make new possibilities a reality, so that our customers can make it matter for patients, every single day..