Job Listing: Clinical Data Manager

POSITION SUMMARY:

The Clinical Data Manager is responsible for processing and reviewing data for all clinical trials.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Coordinate the printing, shipping and receipt of CRFs in multiple studies/sites/countries.
- Process, review, and query clinical trial data using Oracle Clinical database.
- Generate, track, and resolve data queries using data clarification forms (DCFs).
- Perform review of CRFs, issue manual queries as needed, and maintain archiving of CRFs in house.
- Ensure that all processes for data entry and query resolution meet GCP requirements for the entry and reporting of clinical data.
- Author edit checks, data quality plan, and data management plan.
- Assist in the development of databases by assisting in the testing of data entry screens and code lists for clinical study data entry.
- Design case report forms and annotated CRFs.
- Interface with study site personnel to expedite resolution of queries and to improve quality of the data being collected.
- Interface with laboratory personnel, CRF printing vendors, and other vendors as needed.
- Prepare data transfer specs for vendors. Review lab data and immunology data transfers from vendors.

QUALIFICATIONS AND REQUIREMENTS:

- Minimum of four years experience in the Pharmaceutical Industry (biotech, pharmaceutical company, CRO) in a clinical data manager position is required.
- Experience with preparing data for submission for NDA or BLA.
- Bachelor’s degree
- Minimum two years experience using Oracle Clinical to enter and query data in a clinical database
- Knowledge of EMEA and ICH regulations, CDISC, and FDA guidance
- Able to apply GCP to work environment
- Ability to review and understand study protocols and other clinical related materials
- Ability to proactively address issues and to assist in setting project timelines
- Proficiency with Microsoft Office software suite
- Proficiency with auto-encoding, MedDRA and WHO-DRUG coding dictionaries
- Knowledge of current technological developments/trends in data management, database construction, management, and retrieval methods
- Ability to create edit checks, data capture and input specifications
- Communicate effectively, both orally and in writing
- Experience with EDC Systems a plus

Required Skills for Clinical Data Manager Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.