Job Description :
Position: Clinical Data Management Specialist
Location: Thousand Oaks CA or San Francisco CA
Duration: 18 months w/ possibility of extension

Red Flags: The job title (project manager) is a bit generic so it will be good to ensure the candidate has clinical data management experience.
Interview Process: Phone and In-Person

Onboarding / training and getting familiar with future work assignments (e.g. joining meetings, transitioning onto their study team(s), etc.
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.
Oversee our functional service provider (FSP) to ensure quality delivery of data management deliverables (e.g. study start-up, database lock, snapshots, Rave migrations, etc for multiple studies/products.
Collaborate with our functional service provider (FSP) and cross-functional working groups/teams to define new/enhance existing processes for data management activities.
Ensure that Global Study Operations Data Management (GSO-DM) standards, 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 (e.g. DMP, eCRF specs, etc to ensure quality, consistency, and accuracy.
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, project management, organizational, and communication skills are required.
Direct FSP/CRO oversight experience is required and intimate knowledge of data management life cycle is essential for the candidate.
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.