- Review Clinical Study Blueprint (CSB), eCOA Specification (For external vendors), Protocol, eCOA Localization Activities, IRT Specification, IDTS, LAB SOW, Data Transfer Specification, Test Documentations, LAB PSA, Study Specific LAB Test Code list (Master Test Code List Lookup), Data Management Plan, EXECUTIVE DBL Summary Dashboard, EDC Specification (CRF and Edit checks) for oversight and expertise
- Responsible for Adding Resources to TESLA
- Oversee Activities that PDM is responsible for
- Host startup meetings, HOS meetings, vendor oversight meeting (IRT), Study Specific Vendor Oversight Meeting (eCOA)
- Create Data Cleaning plan, HOS slides, Smartsheet Study Specific Project Plans, Standard Deviation Requests, Data Transfer Specification requests, IDRP Shell
- Send Start Up Go Live Notification email (EDC, IRT, eCOA, LSH/SAM)
- Perform Quarterly Query Review process
- Perform Snapshot, Interim Lock and Final Lock Completion
- Send RAND/RNKIT request to vendor
- Send Milestone completion notification emails
- At least a Bachelor's Degree in a Life Sciences field is required\
- 4-6 years of experience managing clinical trial data
- Experience working with Viva & Rave Metadata
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
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Sr. Clinical Data Management Analyst - Chicago - Cognizant
Description
Cognizant is a large IT consulting that leverages modern technologies to transform a variety of business operations. We are seeking a Senior Clinical Data Management Analyst who will be responsible for managing clinical trial data. This person should be a clinical data management professional with a thorough understanding of the end-to-end clinical trial study lifecycle. They should be well versed with study setup, conduct, closeout and archival activities. They should also be able to manage clinical study teams and vendors and have their say from a data management perspective. They are ultimately responsible for keeping the data cleaning on track and need to be in a ready position to meet milestones as planned. Please note that this is a hybrid role in Chicago, IL or Florham Park, NJ. Only local candidates that don't need to relocate will be considered.
Role Responsibilities
Desired Skills & Experience
Salary and Other Compensation:
The annual salary for this position is between $75,000 - $86,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without requiring company sponsorship now or at any time in the future.
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