Bachelor's degree in biomedical sciences, life sciences, computer science, or related field, or equivalent experience.
Minimum 7 years of clinical data management experience in pharmaceutical, biotechnology, or medical device industries.
Expert knowledge of clinical data management best practices and technologies.
Advanced understanding of clinical trial documentation and processes.
Proven ability to lead complex global clinical data management projects independently.
Strong analytical, problem-solving, and decision-making skills with attention to detail.
Excellent communication and interpersonal skills for effective collaboration.
Proficiency in English.
Responsibilities
Lead end-to-end clinical data management activities for global projects.
Ensure effective planning and management of data management deliverables, timelines, and budgets.
Oversee development and review of key study documentation like Data Management Plans and database specifications.
Direct user acceptance testing and data cleaning strategies to ensure high-quality data.
Monitor study progress and proactively identify and mitigate project risks.
Serve as the primary data management representative in meetings, providing expert guidance.
Act as a subject matter expert for data management processes, driving optimization and quality improvement.
Mentor data management colleagues and contribute to departmental initiatives.
Benefits
Remote work opportunity for candidates based in the US.
Inclusive and equitable workplace culture.
Transparent compensation practices.
Competitive benefits package based on location.
Commitment to pay equity and compliance with labor laws.
Full Job Description
Where You'll Work
This is a REMOTE role open to candidates based in US. You will collaborate with global teams across multiple time zones.
What You'll Do
Lead end-to-end clinical data management activities across multiple complex global projects and programs.
Ensure data management deliverables, timelines, budgets, and resources are effectively planned and managed.
Oversee the development and review of key study documentation, including Data Management Plans, database specifications, edit checks, and data transfer agreements.
Direct user acceptance testing, data cleaning strategies, reconciliation activities, and database lock readiness to ensure high-quality study data.
Monitor study progress through metrics and proactively identify, communicate, and mitigate project risks and scope changes.
Serve as the primary data management representative in internal and sponsor-facing meetings, providing expert guidance and leadership.
Act as a subject matter expert for designated data management processes, driving process optimization, training, quality improvement, and CAPA activities.
Mentor and support data management colleagues while contributing to departmental initiatives and operational excellence programs.
Support business development activities, sponsor audits, inspections, and other key stakeholder engagements as needed.
What You'll Bring
Bachelor's degree or higher in biomedical sciences, life sciences, computer science, or a related field, or equivalent relevant experience.
Minimum 7 years of clinical data management experience or related experience within the pharmaceutical, biotechnology, or medical device industries.
Expert knowledge of clinical data management best practices, technologies, and processes supporting clinical trials.
Advanced understanding of clinical trial documentation and processes, including protocols, CRFs, statistical analysis plans, and study reports.
Proven ability to independently lead and oversee complex global clinical data management projects.
Strong analytical, problem-solving, and decision-making skills with exceptional attention to detail.
Excellent communication and interpersonal skills with the ability to collaborate effectively across internal and external stakeholder groups.
Proficiency in English.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $99,000.00 - $196,000.00
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a global contract research organization (CRO) that provides clinical research services to pharmaceutical and biotechnology companies. They specialize in early phase development, late phase development, and full-service clinical research. Worldwide Clinical Trials has experience in a wide range of therapeutic areas, including oncology, neuroscience, and infectious diseases. They are committed to providing high-quality, efficient, and cost-effective services to their clients.
