Clinical Data Manager

Artech Information System LLC; Hanover Township (NJ); On-site; USD 100,000 - 130,000; Full time

Job summary

A staffing solutions company seeks a Clinical Data Manager to lead data management activities. Responsibilities include collaborating with clinical teams, ensuring data quality, and preparing data analysis reports. Candidates should have a Bachelor's degree and 6+ years of relevant experience in clinical data management. This role involves significant collaboration with various stakeholders to establish data management standards and ensure adherence to protocols. The ideal candidate must possess strong analytical skills and attention to detail.

Qualifications

• 6+ years of related work experience with a strong understanding of clinical data management.
• Experience working with clinical documents and various stakeholders (e.g. Project Managers, Clinical Scientists).
• Ability to draft Data Management Plans and contribute to data quality monitoring.

Responsibilities

• Lead data management activities by collaborating with clinical teams.
• Ensure data quality throughout the study and before analysis.
• Prepare and present findings and updates on data management activities.

Skills

Strong understanding of clinical data management

Data analysis and reporting

Problem-solving skills

Attention to detail

Education

Bachelor's degree

Advanced degree (preferred)

Job description

At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.

Job Description

Job Title: Clinical Data Manager
Location: Santa Clara, CA
Duration: 24 Months
Job ID: ABLJP00048431

Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians. Leads data management activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian. May draft Data Management Plans and Data Review Plans as required. Leads the development and defines standard and non‑standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items. Provides significant input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data.

• Leads Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required.
• Contributes to the monitoring of data quality during study conduct and provides information on issues along with proposed solutions.
• Ensures data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs.
• Ensures database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs.
• Ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs.
• Leads the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives.

Qualifications

Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.

Additional Information

All your information will be kept confidential according to EEO guidelines. If you believe you’re qualified for this position and are currently in the job market or interested in making a change, please give me a call as soon as possible at [phone].