ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: CDC
Description:
Serve as a resource tor projects, deliverables. and improvement initiatives in the Data Management department.
Perform data management activities to ensure the generation of accurate, complete, and consistent clinical data, and support timely project delivery to the highest quality.
Ensure all activities are conducted in accordance with Good Clinical Practices (GCP), applicable SOPs, client requirements, and departmental requirements.
Additional Responsibilities:
- Recognize, exemplify and adhere to ICON's valL}es which centers around our commitment to People. Ciients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 0%) domestic and/or international
- Perform Quatity Reviews and appropriately address all issues.
- Compile and distribute necessary study documentation and maintain accurate and complete study flies jn accordance with atl applicable procedures.
- Identify and appropriately address data discrepancies (n the clinical data via computerized edits and manuat checks/listings.
- Independently and accurately generate data queries to resolve data discrepancies.
- Appropriately address responses to data queries and accurately update the clinical data as necessaty.
- Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.
- Independently and accurately prepare database test documentation and test data entry screens.
- Assist with the validation of edit check programs.
- Assist with the development, review, and maintenance of relevant Data Management Study Specific Procedures.
- Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures.
- Accurately perform external data reconciliation in accordance with all applicable procedures.
- Accurately perform case report form annotation.
- Provide input to, generate and distribute status reports as required, ensuring their accuracy.
- Represent Data Management at internal / external meetings as appropriate.
- Serve as a mentor for other staff in Data Management, and provide input to the performance appraisal process as requested.
- Undertake other reasonably related duties as may be assigned from time to time.
Desired Profile:
Minimum of a Diploma or Degree in a Scientific discipline or locai equivalent. or equivalent work experience as described.
Additional Information:
Experience: 2-3 Years
Industry Type: Pharma/ Biotech/Clinical Research
Location: Chennai
Education: B.Pharm, B.Sc
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