To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02406

About our client Our client is the biotech division of a world leading healthcare company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Project Manager, Clinical Data Management Thousand Oaks, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan projects and manage project resources 2) Track and report project status 3) Maintain project documentation and be accountable for its content 4) Coordinate and oversee all CDM clinical trial related activities such as project definition, CRF design, CRF flow definition, DMP preparation, etc. 5) Sign-off on the final locked database delivered for analysis 6) Represent CDM in the project team’s project meetings, timeline discussions, and direct CDM management and the CDM project team 7) Support internal as well as vendor audits to ensure compliance with SOPs and industry standards 8) Work on 2-3 active projects 9) Train CDM personnel on specific projects 10) Supervise professional and hourly staff Requirements 1) BS degree in Life or Computer Sciences (master’s degree preferred) 2) 5+ years of experience in Clinical Data Management (CDM) in a pharmaceutical, biotech, or medical device industry 3) 2+ years of experience in CDM project leadership 4) Experience in managing 3rd party vendors (i.e. CROs, labs) 5) Supervisory experience 6) Understanding and direct experience in all activities supporting a clinical trial from data management's perspective (from protocol review to e-submission) 7) Demonstrated ability to facilitate and manage operational activities that have been contracted out to third party vendors (CROs, labs, etc.) 8) Strong understanding of regulatory requirements and guidelines 9) Ability to work in a multi-disciplinary team and contribute across multiple projects with competing priorities 10) Demonstrated project management skills, including pro-active project planning 11) Proven leadership, decision-making abilities 12) Good organizational skills 13) Excellent verbal and written communication skills