Clinical Data Management Associate
Remote, USA
The Opportunity That Awaits You:We are seeking a detail-oriented and highly organized Clinical Data Management Associate to join our team. This role involves managing clinical study data to ensure accuracy, compliance, and integrity. The ideal candidate will support clinical trials by coordinating data collection, validation, and reporting activities in accordance with regulatory guidelines and company standards. This role reports into the Senior Director of Clinical Affairs.
What Your Day-To-Day Will Involve:
- Data Collection and Management: Coordinate the collection, review, and entry of clinical trial data into electronic data capture (EDC) systems.Perform quality checks to ensure data accuracy and completeness. Data Cleaning and Validation:Develop and execute data cleaning strategies, including query management and resolution.Validate data in accordance with study protocols and regulatory requirements.
- Documentation and Reporting: Prepare and maintain clinical data management documentation, including data management plans, case report forms (CRFs), nd data dictionaries.Generate and review data listings, summaries, and reports for internal and external stakeholders.
- Regulatory Compliance: Ensure data management processes comply with Good Clinical Practice (GCP), ISO 14155, FDA regulations, and other applicable standards.Assist in audits and inspections related to clinical data management.
- Collaboration: Work closely with clinical research associates, project managers, statisticians, and other team members to support trial activities.Provide training and support to site staff on data entry and EDC systems.
The Qualifications We Need You to Possess
- Bachelor’s degree in life sciences, health sciences, computer science, or a related field.
- 1-3 years of experience in clinical data management, preferably in a medical device or pharmaceutical company.
- Experience with EDC systems (e.g., Medidata RAVE, Oracle Clinical, or similar platforms).
- Strong understanding of clinical trial processes, data standards (e.g., CDISC, SDTM), and regulatory requirements.
- Excellent attention to detail and problem-solving skills.
- Proficiency in Microsoft Office and data analysis tools.
- Effective communication and organizational skills.
The Qualifications We Would Like You to Possess
- Domestic and international travel may be required for site training, monitoring responsibilities, and educational seminars. Ability to travel up to 25%.
Understanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers. And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world! BENEFITS OF WORKING AT PROCEPT! PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization. PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role is listed below and represents base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above. WORK ENVIRONMENTWe’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies. Apply
Job Profile
US-based candidates only Work authorization required
Benefits/PerksAnnual bonus Career growth Career growth opportunities Equity/RSUs Transformative opportunities
Tasks- Collaborate with team members
- Coordinate data collection
- Data Analysis
- Data Management
- Develop data cleaning strategies
- Ensure regulatory compliance
- Manage clinical study data
- Perform quality checks
- Prepare clinical data documentation
Attention to detail CDISC Clinical Data Management Clinical Research Clinical trial processes Clinical trials Communication Compliance Coverage Data analysis Data Analysis Tools Data Collection Data Management Data Standards Data Validation Documentation EDC systems FDA regulations GCP ISO 14155 Leadership Medidata Rave Microsoft Office Oracle Clinical Quality Management Regulatory Compliance SDTM Training
Experience1-3 years
EducationBachelor Bachelor's degree in Computer Science Bachelor's degree in health sciences Bachelor’s degree in life sciences Bachelor’s Degree in Related Field Computer Science Related Field
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9