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Clinical Data Manager - FSP

🇨🇴 Colombia

Consulting

Management

Design

Testing

Clinical Data Manager - FSP

from 🇨🇴 Colombia

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring for multiple Clinical Data Manager positions in Colombia, Mexico, Argentina, and/or Brazil.

Job Purpose:

The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide.He/she will participate as an activememberofamulti-disciplinaryteamtoplanand executetheDataManagementtasksrequiredfor phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance

KeyAccountabilities:

  • Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
  • Be able to support several clinical studies with minimalguidance
  • 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.
  • Be able to perform a thoroughly detailed review of eCRF datarequirements.
  • Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completionguidelines.
  • Develop data edit check specifications and run data listings asrequired
  • 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 the Data Management Plan for a clinicalstudy.
  • 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
  • Enter data queries into the EDC system to be resolved atinvestigational sites and manage the resolution of thosequeries
  • Perform reconciliation of header data from external data sources against the clinical database
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Assist in database upgrades/migrations including performing User Acceptance Testing
  • Able to maintain study workbooks and data managementfiles
  • Perform database lock and freeze activities per companySOPs
  • Participate in regular team meetings and provide input whenappropriate
  • Provide input into the development of data management SOPs, Work Instructions, and process documents
  • Contribute to a professional working environment including the application of the client’s Code of Business Conduct andEthics
  • Assist with the training of new employees and/orcontractors 
  • Collaborative relationships
  • Collaborates with cross-functional teams to design andimplement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.
  • Compliance with Parexel standards
  • Complies with required trainingcurriculum
  • Completes timesheets accurately asrequired
  • Submits expense reports asrequired
  • Updates CV asrequired
  • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Knowledge andExperience:

  • At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
  • Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
  • Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
  • Possesses strong English language written and verbal communicationskills.

Education:

  • Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcarefield.
by @maxrusakovic