Senior Clinical Data Manager – FSP
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Job Description
Senior Clinical Data Manager leading data management for Parexel’s global clinical trials. Overseeing EDC systems, database locks, vendors, and regulatory-quality data in Poland.
Responsibilities:
- Lead large clinical studies or a series of related studies with minimal guidance
- Represent Data Management on cross-functional clinical trial working groups for assigned studies
- Oversee and monitor data management activities performed by CROs and external vendors
- Review clinical protocols and provide leadership on data capture strategy, eCRF design, and data collection requirements
- Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to develop annotated eCRFs and completion guidelines
- Lead development of data edit check specifications, data listings, and study-level data management plans
- Coordinate design, testing, and implementation of Electronic Data Capture systems and resolve system-related issues
- Review and provide feedback on study documentation, including monitoring plans, statistical analysis plans, and vendor specifications
- Conduct data reconciliations, including Serious Adverse Event reconciliation and external data source reconciliation
- Lead database upgrades, migrations, user acceptance testing, database freeze activities, and database locks
- Maintain study workbooks, data management files, and study documentation
- Mentor and train data management team members
- Contribute to development of SOPs, work instructions, and process improvements
- Participate in team meetings and contribute expertise supporting study and organizational objectives
Requirements:
- BA/BS degree, preferably in a scientific or healthcare-related field
- At least seven years of experience in Data Management within the pharmaceutical or biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
- Knowledge of ICH-GCP, FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial processes
- Experience with Electronic Data Capture systems and clinical data management technologies
- Strong project management, organization, communication, problem-solving, and multitasking skills
- Proven ability to support Phase 1-4 clinical studies and work effectively with vendors and cross-functional teams
- Familiarity with database upgrades, migrations, user acceptance testing, and advanced data management processes
- Strong English written and verbal communication skills
- Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
- Strengths in clinical data management, project leadership, vendor oversight, and cross-functional collaboration
- Ability to manage multiple priorities while maintaining exceptional attention to detail and data quality
- Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes
- Preferred: Experience within Oncology or CNS therapeutic areas
- Preferred: Experience supporting Phase III pivotal clinical studies
- Preferred: Experience training internal and external study team members on EDC systems and data management procedures
Benefits:
- Permanent, full-time capacity
- Flexibility
- Growth opportunities
- Space to do their best work
- Opportunities to work across global studies
- Continued professional growth and leadership within clinical data management
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