Senior Clinical Data Analyst

hace 6 días

Medellín, Antioquia, Colombia Parexel A tiempo completo

Parexel is seeking a Senior Clinical Data Analyst to support our FSP team.

This is a remote role, open to candidates based anywhere in Argentina, Brazil, Mexico, and Colombia.

The Senior Clinical Data Analyst will independently perform and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with a high degree of proficiency and autonomy.

Responsibilities include providing technical expertise and/or operational leadership regarding all DM operational activities, processes, and Data Management documents regarding data validation.

All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Key Accountabilities:

Accountability

Data Validation (cleaning)

Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), e.g., query management, manual/SAS listing reviews, and external vendor data reconciliation.

Highlight issues/risks to delivery by understanding interdependencies - support mitigations as part of Risk Management Plan.

Data Management Documents/Plans (Trial Master File)

Perform and/or support the setup of DM documents and ensure proper documentation as per Standard Operating Procedures, ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT)

Lead/perform user acceptance testing on clinical database setups.

Review protocols and EDC Entry Screens if required.

Provide input on and tracking the data management timelines and coordinate the DM operational activities during database setup, up to project close-out.

Data Tracking and Entry

Track and review CRFs. Support data entry where required.

Project Quality Management & Compliance

Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.

Perform/Lead functional QC activities on databases and/or patient data, as per business needs.

Training

Maintain training compliance as per Job Roles assigned, including On-the-Job training.

Address training needs, as per Development Goal/s identified.

Provide relevant on-the-job training to staff and project teams as appropriate.

Act as Mentor for other clinical data analysts.

Act as Subject Matter Expert regarding DM operational tasks/tools/processes/systems.

Process/Project Improvement

Develop, improve, and implement project-specific tools, including, but not limited to, standard project directories and subdirectories, document file names, and status reports that result in improved efficiencies.

Project Finance & Resource Support

Determine root cause of operations-related project variance in a timely manner, based on DM operational metrics/labor hour reports - provide input on Changes in Scope needed.

Skills:

Written and oral fluency in English.

Knowledge and Experience:

Advanced technical aptitude with awareness/potential prior experience in Microsoft Office Products (strong computer skills).

Advanced understanding of data management processes and data validation flow (e.g., Data cleaning, DB lock).

Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements, and PAREXEL SOPs and study-specific procedures.

Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g., InForm, Rave, Veeva, DataLabs, ClinBase).

Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g., budget reviews, resource forecast, etc.

Experience in clinical research industry.

Advanced knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).

Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct, and close-out.

Advanced knowledge of Database setup activities, including but not limited to Database Configuration Specifications and setup of Data Validation.

Basic knowledge of SAS (programmed listings).

Basic knowledge of Data standards (CDISC).

Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.

Proven experience of leading virtual/global Data Management operational team/s to perform DB setup, data cleaning activities.

Education:

Bachelor's degree and/or other medical qualifications or relevant industry experience.

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