Clinical Data Management

1+ years

Not Disclosed

Remote

10 April 16, 2025

Job Description

Job Type: Full Time Education: BCS/B.Tech/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Data Manager

Location: Raleigh, North Carolina (Hybrid)
Department: Service Delivery
Employment Type: Full-Time
Minimum Experience: Mid-level
Compensation: $70,000 – $90,000

Job Title:

Clinical Data Manager

Company Overview:

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. Our expertise spans a wide range of therapeutic areas, and we focus on technology-enabled solutions that empower our clients to concentrate on their core competencies. From early-phase to Phase III clinical trials, we deliver high-touch services and innovative tools with a focus on ethics, compliance, and safety across the research community.

Function:

Data Management

Essential Duties and Responsibilities:

Primary Responsibilities:

Review and evaluate clinical data from imaging components of sponsor clinical trials.
Perform all data management deliverables for assigned studies.
Participate in client meetings as required.
Execute study-specific data management plans:
- Understand study implementation requirements.
- Collaborate with project teams to develop edit check criteria.
- Define, run, and review edit checks; resolve discrepant data.
- Maintain organized and current study documentation.
Setup studies including:
- TF design
- Database structure
- Specifications and approvals
Manage and document receipt/processing of electronic or ancillary data from external sources.
Keep supervisors informed of project progress.
Ensure database accuracy and consistency:
- Review and identify data errors/inconsistencies.
- Work with project teams to resolve data issues.
- Track and follow up on outstanding issues.
- Ensure adherence to regulatory guidelines.

Secondary Responsibilities:

Adhere to Sitero CDM procedures, policies, and SOPs.
Assist in enforcing departmental standards.
Contribute to SOP reviews and updates.
Resolve issues with internal staff.
Explore ways to add value to organizational goals.
Support team members in achieving results.
Perform additional duties as assigned.
Attend company-sponsored training sessions.

Education and Experience Required:

Bachelor’s degree in Computer Science, Life Sciences, or a related field preferred (or equivalent experience required).
1+ year of experience in a related role within the pharmaceutical, biotech, or CRO industry.
Familiarity with relational database organization and validation.
SAS knowledge is desirable.
Proficiency in MS Word, Excel, and Access preferred.
Understanding of clinical trial terminology is a plus.
Strong problem-solving skills.
Ability to work both independently and within a team.
Excellent attention to detail and documentation.
Strong communication (verbal and written) and interpersonal skills.
Ability to maintain a professional and positive attitude.

Compensation & Benefits:

Competitive base salary
Discretionary sick leave and paid time off
Healthcare and retirement benefits

Employment Type:

Full-Time, Permanent

Work Commitments:

Standard: 40 hours/week, Monday to Friday, with a one-hour lunch break
Flexibility to work additional hours or shifts as needed

Disclaimer:

Sitero is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected status.

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Clinical Data Management

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