Covance Centralized Study Specialist I in Bangalore, India
Follow applicable departmental Standard Operating Procedures and Work Instructions.
Complete required trainings according to required timelines.
Manage day-to-day tasks ensuring quality and productivity.
Manage project and technical documentation in an appropriate manner.
Provide administrative and technical support to internal departments as needed.
Perform checks to ensure quality of work completed.
Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols
Support implementation of new monitoring tools
Ensure timely escalation and issue resolution.
Track and report metrics as determined by management according to required timelines.
Proactively identifies opportunities for process improvements. Leads the process improvement opportunities and manages the implementation of associated revised processes and procedures.
Support the implementation of departmental tools.
Ability to mentor others.
Other duties as assigned by management.
Manage clinical systems
Manage study documents
Maintain study databases (CTMS, IWRS, EDC etc.
Assist in generating study reports
Manage internal/external communications
Assist in ensuring training compliance for study teams
Manage study payments (Site and Vendor)
Track and follow up with CRAs for outstanding issues
Universiry/College Degree (Life Science preferred) , or certification in a allied health profession from an appropriate accredited institution (E.g Nursing certification, Medical or laboratory technology) and 5-8 years of work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA,IRB/IEC regulations.
In Lieu of the above requirement, candidate with 05 or more years of relevant clinical research experience in Pharmaceutical or CRA Industries may be considered
Years of experience in the job discipline:5-8Years
Years of experience in other professional roles: 0-5Years
Other required work-related experiences:
Demonstrated ability to plan, prioritize, organize and communicate effectively.
Demonstrated ability to pay attention to detail.
Strong interpersonal skills with ability to work well with others.
Ability to deliver consistent high quality of work.
Ability to use computer and departmental tools.
Strong interpersonal skills.
Ability to Influence others.
Ability to facilitate meetings.
Job Number 2018-26841
Job Category Hidden (54284)
Position Type Full-Time
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