Senior Clinical Trials Operations Specialist (Remote)

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 107,000 - 134,000; Full time

Job summary

Sarepta Therapeutics is seeking a Senior Clinical Trial Associate, Clinical Operations for a remote role in the United States with ~10% travel. You will support planning, execution, and management of clinical trials across TMF, documents, and vendor coordination.

The position requires 4+ years in clinical research, a life sciences degree, and strong Excel/Office skills. Some travel is expected; hybrid on-site events may occur as needed.

Qualifications

• Bachelor's degree in life sciences or healthcare related field.
• 4+ years' experience in a clinical research related position.
• Strong computer skills including Excel, Word, PowerPoint and Outlook.
• Ability to work independently and manage multiple priorities.
• Some travel required; the role is remote in the USA with ~10% travel.

Responsibilities

• Coordinate and track distribution and retrieval of clinical documents.
• Maintain inspection-ready TMF according to ICH-GCP and SOPs.
• Support preparation of study-related documents and templates.
• Coordinate trial equipment, supplies, and shipments.
• Review vendor invoices and contracts with oversight of the COL.
• Assist with contract execution and PO generation.
• Participate in cross-functional process improvement initiatives.
• Produce and distribute study newsletters; support trial insurance data.
• Assist with meeting logistics and study team contact lists.
• Liaise with clinical trial sites and vendor contacts as needed.

Skills

Excel

Word

PowerPoint

Outlook

Education

Bachelor's degree in life sciences or healthcare related field

Job description

Sarepta Therapeutics is seeking a Senior Clinical Trial Associate, Clinical Operations for a remote role in the United States with ~10% travel. You will support planning, execution, and management of clinical trials across TMF, documents, and vendor coordination.

The position requires 4+ years in clinical research, a life sciences degree, and strong Excel/Office skills. Some travel is expected; hybrid on-site events may occur as needed.