Independently oversee all aspects of study site management to ensure patient safety and data quality.
Manage site start-up procedures, regulatory submissions, and investigator contracts.
Conduct site visits, remote monitoring, and mentor junior CRAs.
Precision Medicine Group is a global precision medicine company that supports clinical research and development. The company fosters a collaborative culture with a focus on quality and professional growth.
Execute analytical strategies for commercial products, ensuring compliance and method lifecycle management.
Lead method transfer, validation, and investigations at CDMOs, supporting regulatory submissions.
Serve as analytical SME, partnering cross-functionally to ensure quality and supply continuity.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results with a collaborative team.
Lead statistical activities for clinical trials, primarily in Oncology, and act as the lead statistician overseeing strategy and deliverables.
Author key documents including Statistical Analysis Plans (SAPs), Analysis Database Specifications, and statistical sections of clinical study reports.
Collaborate with cross-functional teams, communicate results to stakeholders, and ensure regulatory compliance with FDA, ICH, and GCP standards.
ClinChoice is a global full-service CRO specializing in clinical development for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of experience and 4,000+ professionals across 20+ countries, we foster a quality-driven, one-team culture with below-average turnover and a focus on continuous training.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
Responsible for site monitoring of clinical trials in the Netherlands and Belgium, ensuring protocol compliance and quality.
Prepares accurate monitoring visit reports and ensures integrity of CRF data through source document review.
Provides guidance and mentorship to CRA team, assists with study budget management, and coordinates with cross-functional departments.
Alira Health is a global advisory firm providing consulting, research, and clinical development services to humanize healthcare and life sciences. With over 800 scientists, strategists, and clinicians representing 30 nationalities, they offer a vibrant environment with professional development and flexible work programs.
Lead global Pharmacovigilance Operations, Quality & Compliance strategy to ensure scalable, inspection-ready systems.
Oversee case processing, vendor governance, PSMF, quality systems, audits, and regulatory inspections.
Build and mentor a global team, collaborating cross-functionally to support portfolio growth and commercialization.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.
Leads and oversees global clinical trials from inception through closure, ensuring quality and efficiency.
Manages external vendors, recruitment strategies, and cross-functional team coordination.
Maintains inspection readiness and contributes to risk management and process improvement.
AbbVie discovers and delivers innovative medicines and solutions for serious health issues across immunology, oncology, and neuroscience. The company is a global biopharmaceutical leader with a focus on making a remarkable impact.
Lead strategic development and continuous evolution of the Medical Information function to support COMP360 and pipeline assets.
Oversee development of compliant medical information response documents and collaborate cross-functionally to ensure alignment.
Establish scalable capabilities, metrics, and innovation in technology and service delivery to enhance operational excellence.
Compass Pathways plc is a biotechnology company dedicated to developing new treatment options in mental health care, with a focus on COMP360 psilocybin for treatment-resistant depression and PTSD. The company is headquartered in London, UK, with a US office in New Jersey, and leads one of the largest clinical programs in psychedelic treatments.
Serve as primary contact for data management timelines, deliverables, and technical issues across clinical projects.
Oversee database design, UAT testing, data validation, and quality reviews to ensure compliance.
Train study teams, manage project resources, and support audits and bid defense meetings.
The company is a partner firm managing clinical data for life sciences research. They foster a collaborative, quality-focused culture and support professional development.