Clinical Data Manager

Responsibilities

• Lead or co-lead clinical studies, managing data management activities with minimal guidance.
• Manage and monitor the progress of data management tasks performed by CROs or other vendors.
• Review protocols and design electronic Case Report Forms (eCRF) to ensure appropriate data capture.
• Develop Data Management Plans, data edit check specifications, and CRF completion guidelines.
• Coordinate the design, testing, and implementation of Electronic Data Capture (EDC) systems.
• Manage data queries within the EDC system and perform reconciliation of external data sources.
• Perform Serious Adverse Event (SAE) reconciliation and assist with database lock/freeze activities.
• Collaborate with cross-functional teams, including statisticians and study managers, to ensure high-quality data.

Requirements

• Bachelor’s Degree in a scientific or healthcare field (Master’s degree preferred).
• At least 5 years of Data Management experience within the pharmaceutical or biotechnology industry.
• Proven understanding of Phase I–IV clinical studies and core data management tasks.
• Strong knowledge of regulatory guidelines and industry standards, including ICH/FDA, CDISC, and 21 CFR 11.
• Excellent English communication skills, both written and verbal.
• Strong technical proficiency and the ability to learn multiple computer applications and EDC systems.
• Ability to work independently and as part of a multi-disciplinary team.

Preferred Qualifications

• Prior experience with RAVE or other Electronic Data Capture (EDC) systems.
• Experience or understanding of Oncology or CNS therapeutic areas.
• Experience working on Phase III pivotal studies.

Benefits

• Fully remote, home-based work environment.
• Opportunities for long-term career development and professional growth.
• Participation in performance-based bonus plans and total rewards incentives (where applicable).

About the Company

Parexel is a global leader in clinical research, supporting studies across a wide range of therapeutic areas. We partner with leading global biotechs and top 50 pharmaceutical companies to enable the development of critical medicines for patients worldwide.