Parexel

Senior Clinical Data Analyst – Phase I Experience Required

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; build effective relationships with CRO / vendor counterparts
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
  • Be able to perform a thoroughly detailed review of eCRF data requirements
  • 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
  • Able to resolve EDC system issues with team members
  • Develop or lead the development of the Data Management Plan for a clinical study
  • Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
  • Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
  • Perform reconciliation of header data from external data sources against the clinical database
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Lead database upgrades/migrations including performing User Acceptance Testing
  • Maintain study workbooks and data management files
  • Perform database lock and freeze activities per company SOPs
  • Participate in regular team meetings and provide input when appropriate
  • Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
  • Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics
  • Assist with the training of new employees and/or contractors

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, and a proven ability to perform some of the core Data Management tasks and interact with vendors
  • A high level of Phase I experience is essential
  • 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.) and their application to Data Management practice
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • 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.
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 specificationsElectronic Data Capture (EDC) systemsdatabase upgradesUser Acceptance Testingdata reconciliationclinical database managementdata management plan developmentproject management
Soft skills
leadershipmentoringattention to detailmultitaskingcommunicationteam collaborationrelationship buildingtrainingproblem-solvingprofessionalism