Greetings from American IT Resource Group Inc.!
I would like to touch-base you regarding a job opportunity with our client,
appreciate if you could go through below job detail and let me know your
thoughts as soon as possible.
Reply only to vasa...@aitrg.com
*Role: Clinical Data Scientist (Statistical Science deliverables)*
Location: North Chicago, IL
Duration:6+ Months contract
*Program Lead within Clinical Data Sciences.*
Data Sciences brings people, processes, and technologies together in
support of Client’s clinical trials. Our wide range of accountabilities
span both clinical and operational domains and include development of
clinical systems and management of clinical data, operations and end-user
support for both clinical and operational technologies, clinical and
operational data analytics, and bio-sample logistics and management.
*Primary Job Function*
Provide program-level leadership and promote operational excellence
ensuring successful execution of Data and Statistical Science (DSS)
*Position Accountability / Scope*
§ Accountable for execution and on-time delivery of planned DSS milestones
for clinical technologies from start-up through close-out.
§ Drive DSS study team operations and connect with cross-functional study
teams to deliver trials and programs.
§ Develop and sustain strong relationships between internal stakeholders,
external vendors, cross-functional peers, and DSS senior management.
§ Synchronize deliverables between DSS, offshore resources, and vendors to
deliver outcomes as planned.
§ Influential in setting the strategy for Data Sciences (DS).
§ Management of operations through metrics. Categories include, but are
not limited to, data, systems, general operations, and milestones.
§ Reports into the DS Therapeutic Area leader and has accountability for
global study planning and execution.
*Core Job Responsibilities*
§ Responsible for program/compound-level timelines, while ensuring
compliance and quality.
§ Responsible for the oversight of risk mitigation/risk management and
contingency plans at a program level for all DSS deliverables.
§ Influence and participate in clinical strategy team; including but not
limited to protocol development and clinical technologies.
§ Set expectations with the DSS team, the clinical study team, DS vendors,
TA, and other external teams regarding timelines, processes and general
coordination of the program.
§ Communicate with confidence and leadership with these groups for
prioritizations, actions, and resolutions throughout the life of a program.
§ Act as a point of escalation for internal and external issues.
§ Lead clinical study team in the development of key clinical trial
systems, study conduct and study close-out as related to DSS operational
§ Oversee all Data Sciences timelines and metrics for assigned clinical
§ Lead DSS-related cross-functional meetings with clinical teams, safety
teams and physicians.
§ Oversee all vendor contracts for assigned clinical trials including
accountability for Statement of Work (SoW) and Change of Scope.
§ Participate in DSS-related cross-functional meetings with stakeholders
§ Ensure stakeholder confidence in the health of the study by leading
meetings to effectively communicate expectations, progress, issues and
§ Partner with Total Quality Management Lead to ensure highest quality of
§ Participate in any FDA or other regulatory meetings regarding assigned
§ Influence decisions and approaches through effective negotiation.
§ Ensure quality assurance as a measure to achieve audit and database lock
readiness for assigned clinical trials and programs.
§ Accountable for any audit findings regarding process execution or data
integrity for any assigned clinical trial.
§ Mentor team members
§ Accountable for supporting and utilizing Data Sciences policies and
Looking forward to hear from you!
Thanks & Regards,
Vasanth || American IT Resource Group, Inc.
1111, Plaza Dr., Suite 640, Schaumburg, IL - 60173
Desk: 312-561-4349 || Email: vasa...@aitrg.com
Skype: vasanth.aitrg <vasanth.ai...@gmail.com> || Gtalk: vasanth.aitrg
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