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Michelle Manning

@michellemanning

Clinical monitoring manager at CAIDYA who developed AI-assisted dashboards for CRA performance, compliance, visit activity, and workload.

United States

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At CAIDYA, I managed and developed a team of 10+ CRAs through performance reviews, individualized coaching, and career development. I also advocated for a CRA promotion approved in 2026.

I developed AI-assisted dashboards to monitor CRA performance, compliance, visit activity, and workload, using the findings to guide weekly coaching and follow-up. Previously at SYNEOS HEALTH, I managed teams of up to 21 CRAs and oversaw training, monitoring quality, operational metrics, and ICH-GCP and SOP adherence.

Experience

Work history, roles, and key accomplishments

Manager, Clinical Monitoring

CAIDYA

Oct 2024 - Oct 2026 (2 years)

Managed and developed a team of 10+ CRAs through performance reviews, coaching, and career development. Developed AI-assisted dashboards to monitor CRA performance and compliance.

CRA Line Management Performance Reviews Coaching Career Development Clinical Monitoring ICH GCP SOP Compliance AI Dashboards Data Analysis

Manager, Clinical Operations

Syneos Health

Apr 2022 - Oct 2024 (2 years 6 months)

Managed teams of up to 21 CRAs, providing coaching, performance oversight, and development. Conducted performance evaluations and supported CRA advancement.

CRA Management Performance Evaluation Coaching SOP Compliance ICH GCP Regulatory Requirements Corporate Trainer Recruitment

Clinical Trial Manager II

Syneos Health

Apr 2021 - Apr 2022 (1 year)

Led clinical teams and oversaw site management, monitoring, trial documentation, and GCP compliance. Supported client presentations and bid defenses.

Clinical Trial Management Site management GCP Compliance Client Presentations Bid Defense

Senior CRA II / Clinical Lead

Syneos Health

Apr 2017 - Apr 2021 (4 years)

Coordinated CRA and central monitor activities, overseeing monitoring quality, site performance, and deliverables. Managed risks and alignment with scope and budget.

Site And CRA Coordination Quality monitoring Site Performance Risk Management Budget Alignment

CRA II

Syneos Health

Nov 2014 - Mar 2017 (2 years 4 months)

Performed qualification, initiation, interim monitoring, and closeout visits. Assessed GCP compliance, informed consent, data integrity, and site performance.

Clinical Monitoring GCP Compliance Data Integrity Site Performance Qualification Calls Initiation Visits Close Out Visits

Clinical Research Associate

Syneos Health

May 2012 - Oct 2014 (2 years 5 months)

Managed investigative sites and onsite/remote monitoring activities, regulatory documentation, and protocol compliance.

Site management Remote Monitoring Regulatory Documentation Protocol Compliance

Project Coordinator

Syneos Health

Aug 2010 - Apr 2012 (1 year 8 months)

Supported onboarding, training, mentoring, resource allocation, recruitment, and performance follow-up of Project Research Associates.

Onboarding Training Mentorship Resource Allocation Recruitment Performance Management

Senior Project Research Associate

Syneos Health

Jan 2006 - Aug 2010 (4 years 7 months)

Supported study operations, documentation, timelines, clinical data review, vendor coordination, and investigational product supply oversight.

Study Operation Documentation Timeline Clinical Data Review Vendor coordination Investigational Product Supplies

Project Research Associate (PRA) / PRA II / Senior PRA

PRA Int'l

Jan 2000 - Jan 2006 (6 years)

Supported clinical project management through documentation, plans and timelines, operational reports, databases, change control, client meeting coordination, and presentation materials.

Clinical Project Management Documentation Timeline Operational Reports Databases Change Control Client Coordination