Director of Data Management Ambit Biosciences
THIS JOB HAS EXPIRED Description:
The Clinical Data Manager (CDM) is responsible for ensuring the accurate, complete, and timely collection and delivery of laboratory and clinical data for analysis, reporting, and presentation. The CDM is expected to provide functional expertise to study teams. The CDM will work closely with others to establish priorities and develop strategies for effective execution of data management for all of Ambit?s clinical trials, in order to enable timely regulatory submissions, product approvals, and clinical evidence generation. The CDM will provide oversight and management to ensure all clinical data management activities are conducted in conformance with all relevant laws, regulations, guidelines, policies and procedures, and at the highest possible level of scientific and ethical integrity. They will secure and manage resources from other Ambit functions, independent contractors, and contract research organizations (CROs), as necessary, to ensure project success within established timelines.
Essential Job Functions:
Direct the design, documentation, testing and implementation of clinical data collection studies
Ensure the accurate, complete and timely collection and validation of laboratory and clinical data for research studies
Drive best practices to build database structures, for the effective and efficient maintenance and management of laboratory and clinical data for research studies
Develop standardization and best practices for the construction of datasets for the analysis and reporting of laboratory and clinical data for research studies
Provide early strategic input into protocol design focused on data management issues
Collaborate and coordinates with others to design and implement clinical protocols and data collection systems
Ensure the preparation and maintenance of documentation, as required by departmental standard operating procedures and practices, or regulations
Drive the definition and utilization of data management systems and best practice processes and procedures, in order to support efficient and effective study execution
Develop systems for organizing data to analyze, identify and report data and trends
Provide support to medical affairs activities, such as post-marketing trials and evaluations of medical research grant proposals, which may require data management input
Manage resourcing plans (project deliverables/timelines/budgets) and strategically select a combination of internal/external resources to meet the clinical data management needs of each project
Lead and direct the work of other data managers or independent contractors
Supervise the work of contract research organizations and other external data vendors
Maintain complete records of work performed for assigned projects, and securely archive associated documentation
Oversee the development and maintenance of departmental standard operating procedures
Ensure operation within current compliance guidelines and in line with industry best practices
BS or MS in a relevant scientific discipline or health-related field.
Minimum of five (5) years of relevant experience in clinicaldata management with a biotech/pharmaceutical company. Oncology experience preferred.
COMPETENCIES AND SKILLS:
Demonstrated competency with, and ability to develop and deploy data management processes and procedures
Competency in the utilization of Microsoft tools, specifically Word; Excel; PowerPoint; and/or Project
Proficiency with relational databases and clinical data management systems, particularly RAVE and InForm.
Excellent oral, written and presentation communication skills
Ability to deliver quality results in a timely manner, either independently or by directing others
Excellent organization skills and detail orientation
Excellent negotiation and conflict resolution skills
Ability to be highly effective and influential in a fast-paced environment.
Software Knowledge:Windows, MS Office (Outlook, Word, Excel, PowerPoint), and Adobe. Must have the ability to be trained in new software and equipment as necessary.
Physical Activities: While performing the duties of this job, the employee is frequently required to sit at desk for a long period of time; intermittently answer the telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The employee may need to use their hands to finger, handle, or feel objects, tools, or controls, and reach with their arms. The noise level in the work environment is usually low to moderate. The vision abilities required by this job include close vision and the ability to adjust focus.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
||4215 Sorrento Valley Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED