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Top Echelon Network
Clinical Data Manager III
Job Location: Alameda, CA
Salary: 90000 - 100000
STRONG PHARMACEUTICAL COMPANY in San Francisco, California (great company - publicly traded - heavily funded - great vivacious energy at company) Looking for Clinical Data Manager III see below !!! LOCAL is DEFINITELY first preference (will relo if the person has a reason to be in San Fran - ie: theeir family is there or spouse is relocating for job etc) Will provide Relocation assistance if it is right candidate BUT DEFINITELY will move quick on local candidates!!!
MOVING QUICK!
Also, here are some must-haves for the position:
Currently works in data management
Good organizational skills to manage 5+ studies concurrently experience managing multiple studies concurrently
Experience managing CROs or experience managing people
Clinical Data Manager III
The Company
xxxx, a wholly-owned subsidiary of Major Parent Company, is an innovation-driven biopharmaceutical company based in Alameda, Calif., that is focused on discovering, developing and commercializing a growing portfolio of novel anti-infective therapies for the treatment of serious, antibiotic-resistant infections. At xxxx we conduct our business with the highest moral and ethical standards. We believe that our ability to positively impact peoples health and save lives is directly linked with the experience and insight that our employees possess and how we interact with others. We maintain an environment that recognizes and rewards achievement. We believe in focused goals, individual and team accomplishments. Because of the collective experience of the development and management team, we are able to execute aggressive timelines to achieve realistic outcomes.
The Position
The Clinical Data Manager III is a full time exempt-level position reporting 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.
Key Responsibilities
Manage and coordinate activities of Contract Research Organizations and other 3rd party vendors specifically related to data collection and analysis, and communicate project timelines.
Support the design, documentation, testing, and implementation of clinical data collection and clinical database management across multiple product lines and all phases of clinical development.
Coordinate development of CRFs, edit checks, data validation, and data review guidelines to ensure compliance with study protocol.
Develop strong working relationships and maintain effective communication with Global Clinical Operations, Regulatory, Biostatistics, Programming, and Quality Assurance.
Represent Data Management in clinical project team interactions.
Train team members, as appropriate.
Document and implement departmental and/or team decisions, including assisting with the creation and maintenance of data management documentation.
Develop/design reports and computer programs to assist in the data review process and provide operational metrics.
Evaluate data received from data sources other than CRFs (i.e., central laboratory data) and ensure readiness for analysis.
Maintain knowledge of GCP Guidelines, procedures, and SOPs.
Qualifications and Abilities
Bachelors degree in related scientific discipline and five to eight years related industry experience or equivalent Masters desired
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
Click Here to Apply
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