Clinical Data Manager

Artech Information System LLC; Woodcliff Lake (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Artech Information System LLC is seeking a senior Data Manager with 5–7 years of experience to lead data management activities for clinical trials. The role includes protocol review, CRF development, database setup, data validation, SAE reconciliation, and lab coordination with internal teams and CROs.

The candidate should have strong knowledge of GCP, DM practices, and project management skills, with leadership and communication strengths.

Qualifications

• Bachelor degree or above in scientific or related field.
• Minimum 5-7 years experience in Data Management with experience in managing projects.
• Experience with In-Form or other EDC software is desirable and some oncology study support experience.

Responsibilities

• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database setup, data validation, SAE reconciliation, management of labs and database lock.
• Perform Project Management: represent DM on clinical teams, coordinate deliverables with CRO and other functions.
• Coordinate with Programming to support data review and safety updates (SDTM data retrieval and listings).
• Coordinate CRO data validation activities (data transfer specs, data reconciliation, query generation and resolution).
• Participate in development and implementation of department standards and DM activities.

Skills

Data Management

Project Management

Leadership

Communication

Education

Bachelor degree in scientific field

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