Clinical Data Manager- Fully Remote

The SDC is a collection of diversified professionals who are committed to providing experienced teams that take ownership of client needs and stay positively engaged in projects. We provide top-tier clinical trial services to pharmaceutical, biotechnology, and medical device/diagnostic companies since 2005. Our global team operates in the highest quality of ethics and sustainability by adopting our clients’ needs as our own and delivering exceptional results. We view ourselves as a valued partners to our clients and our proven track record of success has allowed us to grow year over year.

Our commitment to our clients is the same commitment to our employees. By offering strong benefits, focused career development, and a flexible schedule we can attract and employ some of the most talented people in the industry. Energy, Integrity, Engagement, Innovation, Ownership, and Commitment are our core values and the backbone of our culture at SDC.

Take a look at how you can join our team!

Job Summary

Participates in all data management activities in support of clinical and/or non-clinical research studies for study initiation, setup, maintenance, and closeout either as a study lead or backup data manager. Manages the day-to-day data management project activities including, but not limited to, timelines, budgets, staff, project scope, reports, and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Analysts.

• Perform study setup activities including CRF design, database structure design, annotation, document creation and/or approval, data entry screen design and testing, validation check testing and approval, etc.
• Allocate and prioritize workloads for multiple projects (media control, data entry, pre-entry review, and query management tasks)
• Serve as a primary or backup resource for issues pertaining to data management
• Serve as an interim resource for issues pertaining to the study in the absence of the Project Clinical Data Manager
• Assist other Clinical Data Managers or Project Managers with management of timelines and budgets as they pertain to data management activities
• Mentor all levels of Clinical Data Analysts in their job responsibilities
• Maintain quality control of the data, project deliverables, and closeouts
• Support and facilitate the review of medical coding for validity and completeness
• Adhere to all aspects of the SDC’s quality system
• Comply with SDC’s data integrity & business ethics requirements

Requirements

• Competent working knowledge of clinical trials and the clinical data management role in the clinical trials process
• Excellent organizational and project management skills
• Able to lead teams to complete projects
• Highly effective communication skills, both written and verbal
• Technical skills including EDC systems, clinical data management systems, Microsoft Office
• Additional required skills include the following: CRF design, MS Project, and analytical capabilities.
• Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)

Education or Equivalent Experience

• Master’s degree (preferably in engineering, applied or life science) and at least three (3) year of experience in clinical data management or
• Bachelor’s degree and at least four (4) years of experience in clinical trials, or
• Current Certified Clinical Data Manager (CCDM) status and at least four (4) years in clinical trials