Senior Clinical Data Manager – FSP

🔥 0 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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