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
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