Senior Clinical Trial Operations Specialist – Remote

Cognito Therapeutics; Cambridge (MA); Hybride; USD 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Unlimited PTO

Wellness perks

Virtual medical support

Health insurance

Dental insurance

Vision insurance

Résumé du poste

Cognito Therapeutics seeks an experienced Senior Clinical Trial Associate to join our Clinical Operations team in Cambridge, MA. You will support planning, coordination, and oversight of clinical studies, independently managing study workstreams and essential documentation while collaborating with sites, CROs, and vendors.

The ideal candidate brings 5+ years of experience, strong GCP knowledge, and a proactive, collaborative mindset.

Qualifications

• Bachelor's degree with 5+ years of relevant work experience.
• Understanding of clinical development strategies and trial designs.
• Understanding of medical and statistical scientific methodology.
• Working knowledge of GCP and regulatory environment; strong ethics.
• Good communication skills; team player.
• Ability to travel up to 15%.

Responsabilités

• Independently manage assigned clinical trial activities and operational workstreams in compliance with study protocols, SOPs, GCP, and applicable regulations.
• Oversee collection, review, filing, and reconciliation of essential study documentation, ensuring TMF completeness and inspection readiness.
• Manage preparation, maintenance, and reconciliation of Investigator Site Files (ISFs).
• Develop and maintain study trackers, timelines, and metrics to monitor enrollment, site activities, milestones, and deliverables.
• Independently manage assigned vendors and workstreams, including central laboratory activities, study supplies, and vendor deliverables.
• Manage CTMS activities, including data quality, monitoring report tracking, and resolution of outstanding action items.
• Oversee budget activities, including vendor invoice tracking, expense reconciliation, and CRA travel coordination.
• Oversee acquisition, renewal, and tracking of clinical assessment licenses and study materials.
• Coordinate with Data Management on EDC development, testing, data cleaning, and resolution of outstanding queries.
• Manage study system access, including user account setup, maintenance, and access tracking.
• Monitor vendor performance, KPIs, and contractual deliverables, addressing issues as needed.
• Coordinate DMC activities, including meeting prep, materials, minutes, and follow-up actions.
• Identify and resolve operational issues, escalate significant risks to Clinical Operations leadership as appropriate.
• Collaborate with clinical sites, CROs, vendors, and cross-functional teams to ensure timely, compliant execution of study activities.
• Contribute to improvements in Clinical Operations processes, tools, and workflows.

Connaissances

GCP knowledge

Clinical trials

Regulatory understanding

Communication skills

Travel readiness

Formation

Bachelor's degree

Outils

CTMS

Description du poste

Cognito Therapeutics seeks an experienced Senior Clinical Trial Associate to join our Clinical Operations team in Cambridge, MA. You will support planning, coordination, and oversight of clinical studies, independently managing study workstreams and essential documentation while collaborating with sites, CROs, and vendors.

The ideal candidate brings 5+ years of experience, strong GCP knowledge, and a proactive, collaborative mindset.