Senior Clinical Trial Operations Lead

Cognito Therapeutics, Inc.; Cambridge (MA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Unlimited PTO

Wellness perks

Virtual medical support

Health, dental, and vision insurance

Zusammenfassung

Cognito Therapeutics, Inc. is seeking an experienced Senior Clinical Trial Associate to join the Clinical Operations team. You will support planning, coordination, and oversight of clinical studies while independently managing assigned activities and workstreams.

The ideal candidate is highly organized, proactive, and collaborates across functions, with a solid understanding of GCP and regulatory requirements. Travel up to 15% is expected; remote work options are available in a hybrid model.

Qualifikationen

• Bachelor's degree in a related field and 5+ years of clinical operations experience.
• Strong understanding of GCP and regulatory requirements in clinical trials.
• Excellent communication, organization, and problem-solving skills.

Aufgaben

• Independently manage assigned clinical trial activities and operational workstreams in compliance with study protocols, SOPs, GCP, and applicable regulations.
• Oversee TMF completeness, ISFs, and study trackers to monitor timelines and deliverables.
• Manage CTMS activities, budgets, vendor relationships, and data management interfaces.
• Collaborate with sites, CROs, vendors, and cross-functional teams to ensure compliant study execution.
• Support inspection readiness and process improvements in Clinical Operations.

Kenntnisse

Good communication

Team player

Travel ability

Ausbildung

Bachelor's degree (B.A./B.S.)

5+ years of relevant work experience

Jobbeschreibung

Cognito Therapeutics, Inc. is seeking an experienced Senior Clinical Trial Associate to join the Clinical Operations team. You will support planning, coordination, and oversight of clinical studies while independently managing assigned activities and workstreams.

The ideal candidate is highly organized, proactive, and collaborates across functions, with a solid understanding of GCP and regulatory requirements. Travel up to 15% is expected; remote work options are available in a hybrid model.