One Amgen Center Drive Thousand Oaks, California 91320 | Contract
TOP 3 SKILL SETS:
- 5+ years experience in clinical data management in the pharmaceuticals/biotechnology setting with CRO oversight
- Hands-on working knowledge / Experience with Electronic Data Capture (EDC) systems (RAVE ideal)
- Ability to manage multiple projects at once and work effectively in a team dynamic
- Utilize extensive clinical data management experience on multiple assigned projects to accomplish team objectives.
- Meet assigned delivery dates with quality output for assigned tasks and tasks of other team members.
- Manage project deliverable and report progress to team members and management.
- Employ risk identification and mitigation techniques and appropriate escalation as needed.
- Collaborate with cross function team members to ensure appropriate understanding of task.
- Deliver high level of quality in assigned tasks.
- Maintain project timelines and oversight of assigned tasks.
- Collaborate with cross-functional working groups/teams to define new/enhance existing processes for data management activities.
- Influence procedures and processes and how they relate to functional partners such as Global Study Management, Site Management, and Global Biomedical Science.
- Oversee assigned activities as required by the working group/team/manager.
- Ensure that Global Study Operations Data Management (GSO-DM) procedures and processes are adhered to and meet business requirements.
- Accountability for meeting assigned timelines.
- Risk management of assigned projects.
- Point of contact for escalation of issues within the assigned projects.
- Lead activities for assigned project team.
- Communicate with a wide audience both with assigned team and cross-functionally.
- Review related documents and process maps within a project area, ensure consistency and accuracy of content.
- Represent data management on assigned project teams.
- Promote and be an advocate of Data Management internally and externally.
- The ideal candidate should have extensive experience in clinical data management activities within the biotechnology or pharmaceutical industry.
- Strong leadership, organizational and communication skills are required.
- Previous process improvement experience and able to contribute to novel ideas in improving processes are also required of the candidate.
- Direct oversight experience is required and intimate knowledge of data management life cycle is essential for the candidate.