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Data Manager

K3 Innovations, Inc.

This is a Contract position in North Brunswick Township, NJ posted November 29, 2019.

Openings on site in New Jersey.

Various openings are available can be contract or full-time.

Summary of Expectations Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO’s performing data management tasks for assigned study.

Responsibilities Coordinates, leads and performs clinical data management activities for assigned studies in accordance with SOP’s and policies and practices.

Monitors data clean-up process performed from study start-up through data archiving.

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 SOP’s.

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.

Review protocols and identify requirements for data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency, completeness and specified to CDISC standards.

Ensure that SDTM (Study Data Tabulation Model) compliant data is available for analyses, with the Project Data Manager (PDM) and the STDM programmer Ensure real-time inspection readiness of all Integrated Data Services (IDS) deliverables for the trial.

Oversee the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specs and manual data listings to ensure the quality of the data.

Define or review creation and maintenance of all essential data management documentation in the Trial Master File (TMF) to ensure real-time inspection readiness of all CDM deliverables.

Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines.

Proficient with appropriate EDC applications and Microsoft Office applications.

Software proficiency with CDMS required.

Experience with JMP and SAS a plus.

Relevant Experience and Skills A minimum of a Bachelor’s degree in Mathematics, Science or a related field At least 3 years of clinical data management experience in biotechnology, pharmaceutical or health related industry preferred.

Comfortable working with teams and independently to achieve tight deadline goals.

Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines.

Strong analytical and project management skills.

Strong written and oral communication skills required.

Experience with data validation and data standardization is required.

Knowledge of how data flows within the clinical trial process is preferred.

Experience with User Acceptance Testing (UAT) is preferred.

Project management experience is preferred.

Strong leadership skills (i.e.

mentoring, training, etc.) preferred.

Must maintain absolute confidentiality and safeguard sensitive and highly confidential data at all times For any further inquiries or questions feel free to reach out directly.