ClinDatrix is looking to hire a full time in-house Director or Senior Director of Clinical Data Management. The ideal candidate should be located in Southern CA and work in the ClinDatrix office. ClinDatrix is a small service provider, CRO, located in Irvine, CA dedicated to clinical research, data management, and statistical analyses and reporting servicing the biotechnology, medical device, and pharmaceutical industries.
Responsibilities
- Manage and direct all work processes and operations within the Clinical Data Management department to achieve the services promised to our clients at a quality level that meets or exceeds the client’s expectations.
- Hire and manage staff.
- Perform staff training and manage staff development.
- Prepare project bids, project plans, task lists, work flow plans, schedules and performance metrics.
- Oversee all quality control within the department to assure that quality standards are met and that clients receive accurate deliverables within budget and on time.
- Develop new systems and processes.
- Provide input into CRF design, protocol review, edit check specifications, data entry conventions and monitoring guidelines.
- Ensure that complete and auditable documentation is maintained for departmental activities.
- Provide “hands-on” assistance where needed to expedite projects.
- Interface with clients and provide them with accurate reports on their projects.
- Assist the President and CEO with advertising and marketing of ClinDatrix services including bid proposals and client presentations.
- Assist with the development, review and modification of corporate Standard Operating Procedures.
- Perform other general duties as required to support other departments of the company: Information Systems and Technology, Data Management, Biostatistics, Clinical Operations, Medical Safety, and Business Development.
Qualifications and Requirements
- Bachelor’s degree in Arts or Science
- Eight years experience in clinical research and clinical data management
- Knowledge of FDA regulations respecting clinical data quality and clinical trials conduct
- Strong written and oral communication skills
- Ability to work within a team environment
- Ability to manage, motivate, and develop staff
- Ability to manage competing priorities in a changeable environment
- Ability to handle stressful situations and deadlines
- Excellent interpersonal skills
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