Clinical Data Manager 9/6/2016
Palo Alto, CA
JOB DESCRIPTIONThe Clinical Data Manager will:
* Able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
* Able to support several clinical studies with minimal guidance
* Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
* Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. Able to perform a thoroughly detailed review of eCRF data requirements.
* Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
* Develop data edit check specifications and run data listings as required
* Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
* Develop the Data Management Plan for a clinical study.
* Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
* Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
* Perform reconciliation of header data from external data sources against the clinical database
* Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
* Assist in database upgrades/migrations including performing User Acceptance Testing
* Able to maintain study workbooks and data management files
* Perform database lock and freeze activities per company SOPs
* Participate in regular team meetings and provide input when appropriate
* Provide input into the development of data management SOPs, Work Instructions, and process documents
* Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics
* Assist with the training of new employees and/or contractors
* BA/BS, preferably in the scientific/healthcare field.
* At least two years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
* Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
* Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
* Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
* Possesses strong English language written and verbal communication skills.
* Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are desirable.
* Able to travel to off-site meetings or training seminars as needed.
* Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
DESCRIPTION OF PHYSICAL DEMANDS
* Occasional mobility within office environment.
* Routinely sitting for extended periods of time.
* Constantly operating a computer, printer, telephone and other similar office machinery.
DESCRIPTION OF WORK ENVIRONMENT
* Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
* Frequent computer use at workstation.
* May move from one work location to another occasionally.
* Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
* Occasional public contact requiring appropriate business apparel.