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Clinical Data Management Associate

PROCEPT BioRobotics
Remote, USA, United StatesRemotefull_timeVerifiedPosted 21 Jan 2025
💰 $83,000/yr

About the role

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
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%.
For US-Based Candidates OnlyWork Authorization Status: Citizen / Permanent Resident For this role, the anticipated base pay range is $83,000-97,000 per year.Plus, eligibility for an annual bonus and equity/RSUs.
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 opportunit

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Company

PROCEPT BioRobotics

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