Open to opportunities

Amany Takla

@amanytakla

Message

Experienced clinical research leader delivering compliant, on-time clinical programs and high-quality site performance.

Egypt

Message

What I'm looking for

I seek senior clinical operations roles where I can lead cross-functional teams, ensure GCP-compliant delivery, drive study quality, and mentor staff while managing sponsor relationships and timelines.

I am a seasoned clinical research professional with a pharmaceutical sciences background and over two decades of experience across clinical operations, project leadership, regulatory affairs and pharmacovigilance. I have led country and account operations, managed cross‑functional teams, trained investigators and CRAs, and consistently delivered high enrollment, quality trial execution and inspection readiness across therapeutic areas including oncology, haematology, vaccines and pain management.

My career includes progressive roles at Pfizer, CROs and consultancy work where I built monitoring strategies, implemented TMF and quality processes, supported safety activities and mentored junior colleagues. I am committed to compliance, efficient study delivery within budget and timeline, and to developing teams that sustain strong sponsor relationships and measurable operational excellence.

Experience

Work history, roles, and key accomplishments

Account Operations Manager

MCT CRO

May 2022 - Aug 2025 (3 years 3 months)

Managed sponsor accounts and operations to ensure studies were delivered on time, within budget and per ICH-GCP and sponsor standards; supervised Sr. CPLs/CPLs and tracked metrics to improve study performance.

Clinical Operations Project Management ICH GCP Site management Resource Allocation Metrics Team Leadership Stakeholder Management

Senior Clinical Project Lead

MCT CRO

Jan 2022 - May 2022 (4 months)

Led clinical projects ensuring compliance with protocol and timelines, coordinated cross-functional teams and managed study progress reporting and sponsor communications.

Monitoring Risk Management Budgeting GCP

Freelance GCP Trainer

Independent Consultant

Sep 2018 - Dec 2021 (3 years 3 months)

Delivered GCP workshops for junior staff and conducted clinical research consultancies including proposals and job description development for CROs.

Training Development Clinical Consultancy Curriculum Development Mentoring GCP

Associate Site & Resource Manager

IQVIA

Apr 2017 - Feb 2018 (10 months)

Supported resource planning and coached CRAs to ensure high-quality monitoring delivery, conducted accompanied site visits and managed staffing and training for project needs.

Resource Management Monitoring Onboarding Performance Management Clinical Operations

Clinical Operations Manager

TCD MENA

Dec 2016 - Jan 2017 (1 month)

Managed clinical operations, overseeing study delivery and compliance with sponsor and regulatory requirements for regional studies.

Clinical Operations Study Management Regulatory Compliance Team Supervision Sponsor Liaison Risk Mitigation GCP

Clinical Project Leader

RAY CRO

May 2014 - Mar 2015 (10 months)

Managed regional clinical studies and trial operations, reviewed protocols, mentored CRAs and maintained strong sponsor relationships for multinational trials.

Review Protocol Monitoring GCP

Country Manager - Egypt

Phoenix Clinical Research

Sep 2013 - Mar 2014 (6 months)

Led Egypt country clinical research operations, implemented systems and SOPs, managed feasibility and resourcing, and developed clinical teams to support business objectives.

Clinical Operations Budgeting SOP Development Feasibility Assessment

Clinical Operations Lead

Pfizer

Nov 2010 - Nov 2012 (2 years)

Led clinical operations for Egypt & Levant across multiple therapeutic areas, ensured inspection readiness, maintained TMF quality and supported regional study delivery with low error rates.

Clinical Operations TMF Clinical Quality Monitoring Compliance GCP

Clinical Research Lead

Pfizer

Oct 2009 - Oct 2010 (1 year)

Led clinical research activities for Egypt & Levant, mentored junior CRAs and supported quality and monitoring operations across therapeutic areas.

Clinical Research Mentoring Junior CRAs Monitoring TMF GCP

Clinical Research Associate

Pfizer

Apr 2007 - Sep 2009 (2 years 5 months)

Monitored clinical trials across multiple indications in Egypt & the Middle East, contributed to successful audits and maintained high recruitment and low error rates.

Monitoring GCP Data Quality Safety Reporting