One Amgen Center Drive Thousand Oaks, California 91320 | Contract
Top 3 skill sets
1. 7+ years experience in clinical data management in the pharmaceuticals/biotechnology setting with CRO oversight
2. Hands-on working knowledge / Experience with Electronic Data Capture (EDC) systems (RAVE ideal)
3. Ability to manage multiple projects at once.
- Utilize extensive clinical data management experience in study start-up, conduct, and closeout to manage and participate in various projects within the global development process.
- Maintain project timelines and oversight of assigned tasks.
- Oversee a lead data manager working on studies within a drug area to successfully meet all deliverables, on time, and to a high standard of quality.
- Ensure that Clinical Data Management (CDM) procedures and processes are adhered to and meet business requirements.
- Accountability for meeting study/project timelines.
- Lead CDM activities for assigned project team.
- Communication within their assigned product teams globally and cross-functionally.
- Review of all study related documents within a project area, ensuring consistency and accuracy of content.
- CDM representation on assigned project teams e.g. Global Clinical Study Team.
- Support electronic submission activities. Critical to have hyperlinking & submission management experience, including experience with publishing software (i.e. Adobe Professional) and Inspection Readiness activities in support of filing activities.
- Promote and be an advocate of CDM internally and externally
- Extensive experience in clinical data management activities within the biotechnology or pharmaceutical industry and to apply the general processes to assigned process improvement activities.
- Direct oversight experience is required and intimate knowledge of data management study start-up, maintenance and closeout is essential.