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 data management activities independently across multiple complex global projects and programs, from study start-up through conduct, database lock, and close-out.
Plan resources, timelines, budgets, scope, and risks to keep data management deliverables on track and escalate concerns appropriately.
Develop and oversee key trial documentation, including Data Management Plans, database and edit check specifications, completion guidelines, data transfer agreements, and vendor reconciliation specifications.
Drive effective user acceptance testing, data cleaning, reconciliation, metrics reporting, and database lock activities to support accurate and timely clinical data.
Partner with sponsors and internal cross-functional teams, representing Data Management in study meetings and contributing technical expertise and solutions.
Serve as a subject matter expert for assigned data management processes, providing guidance and training while maintaining relevant process and guidance documentation.
Lead responses to process-related quality issues, including root cause analysis and corrective and preventive actions as required.
Mentor Data Management colleagues and contribute to departmental initiatives focused on improving processes, quality, and efficiency.
Support business development proposals and sponsor presentations, and participate as needed in sponsor audits, regulatory authority inspections, and other third-party meetings.
What You'll Bring
Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience, plus a minimum of 7 years of clinical data management or related experience within the pharmaceutical, biotechnology, or medical device industries.
Expert knowledge of clinical data management best practices and technologies as applied to clinical trials.
Advanced understanding of the clinical trial process and key documents, including protocols, statistical analysis plans, CRFs, and study reports.
Strong independent leadership, analytical, and problem-solving skills, with the ability to provide autonomous oversight across complex projects.
Excellent attention to detail and the ability to manage work accurately and effectively.
Excellent communication and interpersonal skills for collaborating with cross-functional internal teams, sponsors, vendors, and other external partners.
Proficiency in English, with strong written and verbal communication skills.
Discover the Difference
We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials. Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.
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.
Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.
