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Clinical Data Management Specialist
Thousand Oaks, CA
Thousand Oaks
CA
91362
Date
: Dec-28-16
2016-12-28
2017-12-28
Clinical Data Management Specialist
Thousand Oaks, CA
Dec-28-16
Work Authorization
US Citizen
GC
H1B
GC EAD
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Senior, Midlevel
Rate/Salary ($)
:
DOE
Duration
:
18 months plus
Sp. Area
:
Other/Multiple Skills
Sp. Skills
:
Bio-Tech
Consulting / Contract
CONTRACTOR
Direct Client Requirement
Required Skills
:
Clinical Data, EDC
Preferred Skills
:
Domain
:
HealthCare, Pharmaceuticals
Work Authorization
US Citizen
GC
GC EAD
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Senior, Midlevel
Rate/Salary ($)
:
DOE
Duration
:
18 months plus
Sp. Area
:
Other/Multiple Skills
Sp. Skills
:
Bio-Tech
Consulting / Contract
CONTRACTOR
Direct Client Requirement
Required Skills
:
Clinical Data, EDC
Preferred Skills
:
Domain
:
HealthCare, Pharmaceuticals
Amerit Consulting
San Ramon, CA
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Position: Clinical Data Management Specialist
Location: Thousand Oaks CA or San Francisco CA
Duration: 18 months w/ possibility of extension
Notes:
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
Description:
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.
Requirements:
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.
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