JOB PURPOSE & IMPACT
Perform a variety of tasks in the coordination and review of final project results. Collaborate with physicians, Project Managers and other departmental staff in the preparation of reporting for BioPharma sponsors.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Gather, compile and complete quality review and inspection (proofread) of test reports for format, text, and signatures; ensure consistency with and accuracy as it relates to established standards.
Interface with Project Managers and internal laboratory staff to prioritize project deliverables, monitor and document progress, resolve issues and provide timely updates to team members.
Assist in authoring SOPs, work instructions, internal control documents, and training aids.
Assist in evaluating project performance and recommend process improvements.
Provide input for the configuration and refinement of LIMS, design specifications for new report layouts and test methodology macros.
Transcribe data from test reports into Sponsor eCRFs.
Assist with interim and end of study data transfers.
Compile bioanalytical and close out reports for BioPharma sponsors.
Coordinate internal training of new members on study projects.
Complete related administrative duties, such as identification and retrieval of completed clinical trial subject case folders, copying, filing, data entry, faxing, QC of spreadsheets and data transfer files.
Complete other related duties as assigned.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associates degree in a science related field with a minimum of five (5) years relevant experience OR
Bachelors degree in a science field (preferably biology, biochemistry or molecular biology and a minimum of two (2) years experience in a clinical laboratory setting or one (1) year as a Clinical Research Associate.
Years of Experience Required:
Required Skill Sets & Knowledge
Demonstrated knowledge and/or understanding of science as it applies in a laboratory setting.
Proficiency using Microsoft Office programs especially Excel, Word, and Outlook.
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