Clinical Data Manager
Department:
Service Delivery
Employment Type:
Full-Time
Minimum Experience:
Mid-level
Compensation:
$70,000 - $90,000
Location:
Raleigh, North Carolina (Hybrid)
Company Overview:
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We bring experience and expertise across a wide range of therapeutic areas and focus on delivering innovative, technology-enabled solutions that allow clients to focus on their core strengths. For early-phase studies through Phase III clinical trials, our experienced team ensures the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Description:
The Clinical Data Manager is responsible for reviewing and evaluating clinical data generated from the imaging portion of sponsor clinical trials across various therapeutic areas. This position ensures clinical trial databases meet project requirements and are maintained with accuracy, consistency, and regulatory compliance.
Essential Duties and Responsibilities:
Primary Responsibilities:
Review and evaluate clinical data generated from sponsor clinical trials.
Perform all data management deliverables for assigned studies.
Attend and participate in client meetings as requested.
Understand study implementation and data collection requirements.
Collaborate with project teams to develop study-specific edit check criteria.
Define, run, and review edit checks; resolve discrepant data.
Maintain organized, complete, and up-to-date study documentation.
Perform study setup, including TF design, database structure, and specifications.
Coordinate and document the receipt and processing of electronic or ancillary data from external sources.
Keep supervisors informed of project status.
Review data to identify errors/inconsistencies and work with project teams to resolve them.
Track outstanding issues and ensure resolution.
Ensure accuracy in data manipulation and that activities comply with regulatory guidelines.
Secondary Responsibilities:
Adhere to all Sitero Clinical Data Management (CDM) procedures, policies, and work instructions.
Read, understand, and comply with applicable Standard Operating Procedures (SOPs).
Assist in establishing and enforcing departmental standards.
Participate in the review and updating of company SOPs related to Data Management Services.
Work with internal staff to resolve issues and support company initiatives.
Explore new opportunities to add value to the organization.
Support others in achieving project results.
Perform other duties as assigned.
Attend and participate in applicable company-sponsored training.
Education and Experience Required:
Bachelor’s degree in Computer Science, Life Sciences, or a related field preferred, or equivalent experience required.
Minimum of 1 year of experience in a comparable position within the pharmaceutical, biotech, or CRO industry.
Working knowledge of relational database organization and validation.
Familiarity with SAS is desirable.
Experience with office productivity tools such as Word, Excel, and Access is preferred.
Understanding of clinical trial terminology is desirable.
Proven problem-solving abilities.
Ability to work independently and adjust to changing priorities.
Excellent attention to detail.
Strong interpersonal and communication skills, both verbal and written.
Strong documentation and organizational skills.
Ability to project and maintain a professional and positive attitude.
Compensation and Benefits:
Sitero offers a competitive salary, discretionary sick leave, paid time off, healthcare benefits, and retirement benefits.
Commitments:
Standard working hours: 40 hours per week (Monday–Friday) with a one-hour lunch break.
Willingness to work additional hours and shifts as needed.
Disclaimer:
Sitero is an equal opportunity employer and welcomes all applicants. All qualified individuals will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
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