Clinical Project Manager Jobs
Alameda, CA
CLINICAL DATA MANAGER
COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries.? We specialize in the nationwide recruitment of clinical trials personnel.
Our client is a biopharmaceutical company focused on discovering, developing and commercializing a growing portfolio of novel anti infective therapies for the treatment of serious and life threatening infections and is seeking to add a Clinical Data Manager to their team in Alameda, Ca.
JOB SUMMARY:
The Global Clinical Data Manager reports to the Sr. Director, Biostatistics.? This position coordinates data collection, storage, analysis and reviews conventions across many studies and multiple products in various phases of development.
RESPONSIBILITIES:
- Direct the design, documentation, testing, and implementation of clinical data collection, and clinical database management across multiple product lines and all phases of clinical development.
- Develop systems for collecting, organizing, coding, storing and analyzing data for the company\\\'s research purposes.
- Collaborate and coordinate with others to assist in the design of clinical protocols, CRFs and statistical analysis plans.?
- Provide early strategic input into the data management issues associated with clinical programs.
- Maintain responsibility for standardization of CRF design and data management conventions across multiple programs.
- Assist in the strategy and selection of Contract Research Organizations and other 3rd party vendors to assist with data management functions of the company.
- Manage and coordinate activities of Contract Research Organizations and other 3rd party vendors specifically related to data collection and analysis.
- Develop strong working relationships and maintain effective communication with Global Clinical Operations Managers.
- Ensure proper validation of all systems, conventions and procedures employed in data management processes.
- Ensure data management requirements, associated timelines and budgets are well understood by clinical operations personnel and other personnel associated with data management functions.?
- Act as a key contributor to the organization cross-functionally to promote organizational goals and knowledge sharing.
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QUALIFICATIONS:
- Excellent written and verbal communication skills
- Skilled at presenting complex ideas and sharing knowledge
- Strong organizational, communication and prioritization skills
- Ability to handle multiple projects and work in a team environment
- Able to develop excellent internal and external collaborative relationships
- Experience with coding dictionaries (WHO, COSTART, ICD-9, MedDRA)
- Proficiency with Microsoft Word, Access, Excel, PowerPoint and PageMaker experience with database design and development expertise preferred
- Knowledge of SAS, ClinTrial, Oracle, Oracle Clinical, or SQL databases required
EDUCATION:
- Bachelor's degree in related scientific discipline and five to eight years related industry experience or equivalent.
- Masters desired
For more information please call 800-256-4625
