Senior Study Start-Up Lead: Trial Activation & Ops

Cognitive Research Corporation; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Cognitive Research Corporation is seeking an Associate Director of Clinical Operations focused on Study Start-Up. You will lead the Start-Up team, drive timelines from study award through site activation, and partner with PMs, regulatory, contracts, QA, and vendors to ensure timely, compliant activations across trials.

Travel up to 10% may be required. You will oversee IRB submissions, essential documents, budgets, and CTAs, ensuring quality and sponsor expectations are met in a fast-paced,

Qualifications

• BS/BA in life sciences or related field; advanced degree preferred.
• 10 years of experience in clinical research/operations/start-up or related field.
• Significant study start-up experience in CRO/pharma/biotech settings.
• Direct people-management experience in a study start-up/clinical ops context.
• Strong knowledge of study start-up processes (IRB submissions, site activation, contracts/budgets).
• Familiarity with ICH-GCP and regulatory expectations; excellent communication.

Responsibilities

• Lead and develop CRC’s Study Start-Up team.
• Oversee start-up plans, timelines, and site activation.
• Coordinate CDAs, feasibility, IRB submissions, and essential documents.
• Manage budgets, contracts, and site activation readiness with stakeholders.
• Monitor KPIs, escalation pathways, and process improvements.
• Partner with cross-functional groups for timely study activation.

Skills

Team leadership

Clinical operations

Study start-up

Regulatory submissions

Budgeting & contracts

Vendor management

Cross-functional collaboration

CTMS/eTMF/TMF

Education

BS/BA in life sciences

Advanced degree preferred

Tools

CTMS

eTMF/TMF systems

SharePoint

Monday.com

Job description

Cognitive Research Corporation is seeking an Associate Director of Clinical Operations focused on Study Start-Up. You will lead the Start-Up team, drive timelines from study award through site activation, and partner with PMs, regulatory, contracts, QA, and vendors to ensure timely, compliant activations across trials.

Travel up to 10% may be required. You will oversee IRB submissions, essential documents, budgets, and CTAs, ensuring quality and sponsor expectations are met in a fast-paced,