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Job Field: Legal Jobs
Location: San Diego, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Working independently and reliably showing a high
level of ownership, also analytically minded with
a strong focus on detail and committed to quality
deliverables the Project Specialist collects and
analyzes operational information of various
sources including web based IT to present high
level trends and conclusions to the Project Leader
thus facilitating the project planning and
decision making process. In addition the Project
Specialist provides support to the Clinical
Operations Lead COL and Data Operations Lead
DOL on specific tasks. As a strong team player
the Project Specialist is able to communicate with
various internal and external functions.
Key Accountabilities
- In general provide internal support to Project
Leader, COL, DOL as a project resource supporting
internal systems and systems set-up but also
executing day-to-day data analysis of the
operational study status planned versus current
and reporting activities
- Prepare draft project plan including all sub
plans Communication plan, Risk Management plan,
MSP, WSOP listing, Quality plan, etc. for team
discussion before Kick-off meeting
- Develop and maintain Central Files Maintenance
Plan CFMP in co-operation with Project Leader
and project team, support implementation according
to the CFMP and oversee quality checks according
to the plan
- Prepare project documents and status reports for
Project Leader
- Prepare study recruitment plan in co-operation
with SMO Site Management Organization and COL
which outlines key recruitment challenges for the
trial and corresponding strategies to meet the
milestone, monitor compliance to the plan and
report status to Project Leader
- Responsible for assigned tool management
including set up and maintenance of the
recruitment planning tool SPARC in co-operation
with SMO maintain investigator /supplier portal
- Initiate, set-up and maintain Management Systems
on a regular basis GXDB, CTMS, PMED, other
systems as required
- Develop routine Client Report format with
Functional Leads using standard reports where
possible, may be involved with ad hoc client
requests for reporting
- Arrange project related training for new
project team members under the direction of the
Project Leader, COL, DOL and maintain project
specific trainings overview and records including
study specific system training and access for PI,
new site staff, study team and new study team
members e.g. IVRS, e-CRF
- Attend project specific training as required and
per SOP and Work Instructions
- Oversee implementation of Quality Plan, perform
Project Management related quality checks on the
study according to Quality Plan and in close co-
operation with Project Leader e.g. Study Manual,
CRF completion guidelines
- Support Project Leader in identifying,
implementing, reviewing and up-dating project
specific operational performance metrics
- Support Project Leader in appropriate selection
of third party suppliers, manage internal
procurement process, ensuring that appropriate
Scope of Work documents and Purchase Requisitions
are in place...For more information please go to
URL.

KEY REQUIREMENTS:

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None Bachelors degree