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Job Title: Senior Clinical Data Manager
Work Location: Emeryville, CA
Length of Assignment: 6 Months
Client: A Big Pharmaceutical Company
The Senior Clinical Data Manager provides technical & operational expertise to the project teams & is responsible for ensuring the data collected meets the requirements of the study objectives for the purpose of clinical study reports, publications, & regulatory submissions.
This position will lead & coordinate functions for multiple assigned projects related to the planning, execution, collection, & cleaning of clinical data. S/he will work within the company's SOPs, guidelines & standards to ensure data integrity at all times.
Lead CRF design & guidelines for population of CRFs.
Work with clinical operations group, biostatisticians, SAS programmers to develop CRFs to ensure required information is captured for statistical analysis.
Implementation of CRFs in the database & assuring that the database for each study is live in a timely manner.
Oversight of all clinical data management activities, database cleaning & lock activities including developing data management plans, supervising database development & reviewing & processing clinical trial data to ensure completeness, accuracy & consistency of clinical trials databases.
Lead interactions between company & outside vendors on the collection, transmittal & transfer of study specific instrument & laboratory data.
Participate in cross functional team meetings & communicate with all departments regarding project statuses/issues
Work with biostatisticians & SAS programmers to harmonize data collection, compile & maintain SAS data standards.
Provide review & oversight on quality database design, validation, & deployment to ensure quality & efficiencies through data & process standardization.
Review clinical study protocols, statistical analysis plans & ensure data quality for data analyses.
Take a leadership role in the review & query of clinical data. This includes participation of the critical review of data-populated tables, figures, & listings as part of the database clean-up & prior to database lock.
Scope of Work:
Educate study team members by preparing & distributing study related reports, resolving questions & providing clinical data management guidance.
Assure regulatory compliance of vendors & investigational sites with company SOPs, FDA & ICH guidelines, & other applicable regulations & guidelines.
Develop & maintain appropriate data management SOPs (associated with the data collection, h&ling & review processes to meet regulatory compliance & operational needs).
Assist in addressing Regulatory Submission issues within Biostatistics & with other related departments.
Assist with response to questions & findings from audits at the study/vendor level.
Utilize appropriate CDM concepts & resources to solve moderately complex technical CDM issues.
Ensure data management procedures & projects have set timelines & meet established deadlines.
Manage & maintain effective communication with project management.
Serve as a technical resource for data management related activities; troubleshoot technical problems.
Experience with Electronic Data Capture (EDC)
Excellent verbal & written communication skills & strong interpersonal skills
Experience managing Clinical Research Organizations (CROs)
Familiarity with clinical data management systems
SAS programming experience a plus
Analytical & Communication skills
Planning & Co-ordination skills
Experience with project management
Experience with DataTrak a plus.
Interested candidates can share their most updated resume at email@example.com or they can reach out to me on #973-967-3412 Ext: 3412
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