Associate Director/ Director, Clinical Data Management

job summary:
The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.

location: Warren, New Jersey
job type: Permanent
salary: $160,000 - 200,000 per year
work hours: 9 to 5
education: Bachelors

responsibilities:

• Ensure the data collected meets the requirements of the study objective and company quality standards.
• Assist in the development and implementation of strategic vision for data management (DM) group.
• Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis.
• Oversee coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding

qualifications:

• Bachelor's degree in science or related field (such as healthcare)
• Minimum of 10 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.

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skills: Data Management Plan, EDC (Electronic Data Capture)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.