Job Description
Are you passionate about clinical data management and looking for a role where your expertise can make a meaningful impact? Join a collaborative and innovative team dedicated to advancing clinical research through a scientific approach to complex trial data and regulatory challenges. Here, you'll find a supportive work environment that values your contributions, encourages growth, and fosters a strong sense of community.
This is your chance to be part of a team that combines cutting-edge solutions with a commitment to excellence, ensuring a thriving career in clinical research.
Key Responsibilities
Deliver outstanding internal and external customer service, maintaining strong professional relationships.
Utilize expertise in multiple EDC systems to guide clients on the best-fit solutions.
Act as a key contact for data management suppliers, negotiating and ensuring business needs are met.
Coordinate directly with clients on all facets of projects, building and sustaining robust client relationships.
Oversee the complete data management process, from study setup to closeout, ensuring high-quality results.
Review study protocols with clients, providing actionable feedback for successful database design.
Maintain strong knowledge of GCP/ICH guidelines and FDA regulations related to data management.
Mentor and train new clinical data managers, fostering growth and expertise within the team.
Manage and resolve issues in key activities like CRF tracking, data entry, validation, coding, and database lock.
Prepare and oversee study documentation, including CRFs, CRF Completion Guidelines, annotated CRFs, validation specs, and Data Management Plans.
Lead user acceptance testing (UAT) for study-specific systems and applications.
Collaborate across teams to meet study timelines and milestones.
Drive process improvements, SOP updates, and DM systems enhancements.
Participate in organizational initiatives, providing expert input on project management processes.
Requirements
A Bachelor's or Master's degree in a scientific or healthcare field (preferred) with relevant industry experience.
At least 5 years of experience in data management, with 1+ years leading projects.
Deep understanding of paper CRF, EDC, and hybrid CDM systems.
Strong knowledge of clinical operations SOPs and working practices.
Excellent communication, interpersonal, and organizational skills.
Confidence in articulating data management services to clients, including during bid defense meetings.
A proactive attitude with the ability to work independently, lead projects, and resolve challenges effectively.
What We Offer
A fully remote role with flexibility to support your work-life balance.
A team-focused culture that values your professional growth and celebrates your contributions.
Opportunities to expand your knowledge in the field of clinical research and drug development.
If you're ready to take the next step in your career and join a forward-thinking organization dedicated to excellence in clinical research, we'd love to hear from you.
Employment Type: Full-Time
Salary: $ 115,000.00 Per Year
Job Tags
Full time, Remote job,