clinical data manager

Artech Information System LLC; Jersey City (NJ); On-site; USD 90,000 - 110,000; Full time

Job summary

A leading IT staffing company in New Jersey seeks a Data Management Specialist with 5-7 years of experience. The role involves managing DM activities for clinical trials and coordinating with various teams. Candidates should have a bachelor's degree in a related field, project management skills, and experience with EDC software. Strong communication and leadership skills are essential for success in this dynamic role.

Qualifications

• Minimum 5-7 years experience in Data Management.
• Experience in managing projects and project teams.
• Proficiency on regulations, GCP, and Good Clinical DM Practice.

Responsibilities

• Perform DM activities for in-house and outsourced trials.
• Coordinate deliverables by other functions to achieve DM deliverables.
• Support data review and safety updates with the Programming team.

Skills

Project management skills

Strong oral and written communication skills

Leadership skills

Education

Bachelor degree or above in scientific or related field

Tools

In-Form or other EDC software

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock.
• Perform Project Management : represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables.
• Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM,)
• Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution,
• Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed.

Qualifications

Bachelor degree or above in scientific or related field Minimum 5-7 years experience in Data Management with experience in managing projects, project teams. Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies. Must be able to work independently. Proficiency on all related regulations, GCP, and Good Clinical DM Practice. Project management skills required. Strong oral and written communication skills. - Leadership skills a must