Senior Clinical Data Analyst – Medical Device

📋 Description

• Act as a key member of the project team, primarily responsible for coordinating clinical data reviews, generating and resolving queries, and managing reconciliation activities to support the Data Management lead.

• Assist in creating the project Data Management Plan, which includes establishing data review guidelines and diagnostics specifications.

• Ensure that all assigned projects are executed in strict compliance with relevant protocols, globally harmonized Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) standards.

• Conduct all necessary data management tasks, including data reviews and query management, to ensure adherence to quality standards.

• Generate, resolve, and monitor queries to address any data issues identified during aggregate data review processes.

• Collaborate with other project team members to facilitate the setup, maintenance, and closure of the Data Management components of the project.

• Execute database extracts and assist in completing Database Lock activities.

⛳️ Requirements

• A university or college degree in life sciences, health sciences, information technology, or related fields, or a certification in allied health professions from a recognized accredited institution.

• Proficiency in English, both written and spoken.

• 2 to 4 years of relevant experience in clinical research, with a preference for data management.

• Familiarity with clinical Electronic Data Capture (EDC) systems.

• Understanding of medical terminology.

• Proven time management skills with the ability to meet project productivity metrics and deadlines.

• Ability to work effectively in a team setting and collaborate with colleagues.

• Strong organizational skills, along with excellent communication and interpersonal abilities.

• Demonstrated teamwork, collaboration, analytical, and reasoning capabilities.

• Knowledge of effective clinical data management practices.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options