Parexel

Senior Clinical Data Analyst – FSP

Parexel

full-time

Posted on:

Location Type: Remote

Location: Poland

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Salary

💰 PLN 195,000 - PLN 223,000 per year

Job Level

Senior

About the role

  • Lead a large clinical study or a series of related studies with minimum guidance
  • Represents Data Management on the CTWG for assigned studies
  • Provide mentoring and training to lower-level Data Management staff assigned to your studies
  • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
  • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
  • Lead the development of data edit check specifications and data listings
  • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards
  • Develop or lead the development of the Data Management Plan for a clinical study
  • Perform database lock and freeze activities per company SOPs
  • Provide input into the development of data management SOPs, Work Instructions, and process documents

Requirements

  • Bachelor’s Degree required, preferably in the scientific/healthcare field
  • Proven leadership experience
  • Good project management skills and a proven ability to multitask
  • At least five years’ or preferably up to 8 years' experience in Data Management for the pharmaceutical/biotechnology industry
  • Understanding of the scope and focus of Phase I – IV clinical studies
  • A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.)
  • Attention to detail
  • Strong English language written and verbal communication skills
  • Able to travel to meetings or training seminars on occasion
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications
  • Prior experience with different Data Management systems and technologies and Electronic Data Capture systems is desirable
  • Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
Benefits
  • participation in Parexel’s annual performance-based bonus plan
  • annual salary review
  • total rewards incentives
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
data managementelectronic Case Report Form (eCRF) designdata edit check specificationsdata listingsElectronic Data Capture (EDC) systemsData Management Plandatabase lockfreeze activitiesregulatory guidelinesCDISC standards
Soft Skills
leadershipproject managementmultitaskingattention to detailcommunication skills