Clinical Data Temp-Data Manager (CDM) - REMOTE New Jersey

Orbis Clinical is seeking a remote-based Temp-Data Manager for 6 months with the possibility for extension.

Job Title: Temp-Data Manager

Location: Remote

Contract: 6 months with the possibility for extension

Summary:

Works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual (DMM). Works with involved parties to assure that DMM is prepared according to company SOPs and in compliance with Company’s data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Company’s SOPs and policies and practices.

Job Responsibilities:

• Serves as primary DM contact for assigned studies, including representation on project teams and working with CROs performing data management tasks for assigned study.
• Coordinates, leads and performs clinical data management activities for assigned studies in accordance with Company’s SOPs and policies and practices including, not limited to:
  • Monitors data clean-up process performed by CROs from study start-up through data archiving.
  • Provides data for analysis.
  • Coordinates activities including: medical coding; data validation checks and database snapshot.
• Prepares and distributes project status reports to project team and management.
• Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with Company SOPs.
• Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.
• Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities.
• Contributes to upkeep Company DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.
• Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures.

Education

• Bachelor’s degree in Mathematics, Science or a related field, along with 3 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry.

Experience

• 3 – 5++ Years of exp.
• Previous oncology and/or hematology experience a HUGE plus!

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $76.08 – $80 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.