Orbis Clinical is seeking a remote-based Clinical Data Manager for 12+ months.

The Clinical Data Manager will be responsible for supporting the execution of clinical trials by ensuring the accuracy, integrity, and quality of clinical trial data. This role will focus on hands-on data management activities including clinical data review, reconciliation of Serious Adverse Events (SAEs) and external vendor data, query management, and preparation of data deliverables. The Clinical Data Manager will collaborate closely with cross-functional study teams, statisticians, and external vendors to ensure study milestones are met and regulatory standards are upheld. This position requires strong attention to detail, a solid understanding of clinical data management principles, and the ability to work effectively in a fast-paced, dynamic environment.

Job Description

• Manage clinical data management activities for assigned studies to ensure high-quality, complete, and reliable study data.
• Conduct ongoing data review, including performing SAE reconciliation, external vendor data reconciliation, and data cleaning in alignment with study timelines.
• Contribute to the design and testing of electronic Case Report Forms (eCRFs), edit checks, and validation rules; participate in User Acceptance Testing (UAT) to confirm system functionality.
• Develop and maintain study-specific data management documentation (e.g., Data Management Plan, Data Review Plan, CRF Completion Guidelines, data validation specifications).
• Generate, review, and resolve data queries, ensuring consistency and compliance with study protocol and standards.
• Support preparation for interim analyses, database lock, and final data deliverables in collaboration with statisticians and programmers.
• Maintain inspection-ready documentation and ensure data management activities are conducted in compliance with SOPs, ICH/GCP, and regulatory requirements.
• Participate in study team meetings and provide updates on data management status, issues, and risks.
• Contribute to process improvement initiatives and share knowledge of best practices across the data management team.

Requirements:

• Bachelor’s degree in life sciences, computer science, or related discipline.
• 4–6 years of experience in clinical data management, preferably in oncology.
• Solid understanding of clinical trial processes, data management principles, and regulatory requirements.
• Hands-on experience with EDC systems (Veeva CDMS strongly preferred).
• Familiarity with medical coding dictionaries (MedDRA, WHO Drug).
• Strong working knowledge of ICH/GCP guidelines, FDA regulations, and CDISC standards.
• Proficient in EDC configuration, data validation, query management, and external data integration.
• Excellent attention to detail with strong problem-solving and analytical skills.
• Effective communicator with the ability to collaborate across cross-functional study teams.
• Ability to prioritize multiple tasks and adapt in a fast-paced, changing environment.
• Results-oriented, self-motivated, and committed to delivering high-quality work.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $70-$80 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.