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Lead Data Manager

Novartis Pharmaceuticals Corporation

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Location:
East Hanover, NJ
Posted Date:
7/23/2014
Position Type:
Full time
Job Code:
139991BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Provide timely and professional ongoing management of project & clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines. Serve as Trial Data Manager for multiple trials and may act as a PDM for small study programs; Provide input on CTT(s)/GCT (s). Assist Project Data Manager to ensure consistency of Protocols, Validation and Analysis Plans (VAPs) & eCRFs for all trials within assigned projects. Responsible for contributing to protocols and preparing the eCRF, CCG, VAP, database design testing (UAT), identifying errors and inconsistencies, freezing and locking database as appropriate). May respond to Health Authority requests for data management issues. Support and assist Assistant Data Managers and other Data Managers for allocated trials within assigned project(s). Provide input, review, and maintenance of global working practices and standards. Contribute to the development of the local Data Management group through his/her leadership role within the group. Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases. Ensure appropriate Novartis tracking systems are up to date and accurate. Participate in clinical & non-clinical special projects. Assist in coaching, training and mentoring of Data Management staff.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or 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.

This position will be filled at a level commensurate with experience.
Local candidates preferred
Minimum requirements  Bachelor degree required (life science, computer science, pharmacy, nursing, related is preferred) Fluent English (oral and written). Ideally 4+ years of related experience in drug development, with at least 3 years in Data Management activities. Trial Management experience required. Good technical and problem solving skills. Thorough understanding of clinical trial methodology, GCP and medical terminology. Ability to work independently, under pressure, demonstrating initiative and flexibility. Attention to detail and quality focused. Good organization and planning skills. Basic project management skills. Through understanding of physiology, pharmacology, clinical study objectives and the drug development process. Ability to mentor and coach within Data Management. Good interpersonal and communication skills and the ability to operate effectively in an international environment.

Requirements

Bachelor degree required (life science, computer science, pharmacy, nursing, related is preferred) Fluent English (oral and written). Ideally 4+ years of related experience in drug development, with at least 3 years in Data Management activities. Trial Management experience required. Good technical and problem solving skills. Thorough understanding of clinical trial methodology, GCP and medical terminology. Ability to work independently, under pressure, demonstrating initiative and flexibility. Attention to detail and quality focused. Good organization and planning skills. Basic project management skills. Through understanding of physiology, pharmacology, clinical study objectives and the drug development process. Ability to mentor and coach within Data Management. Good interpersonal and communication skills and the ability to operate effectively in an international environment.

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