Jobs at Parexel
Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.
Data Management Lead IJob ID 69752BR Romania - Any Region - Home Based
General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.
May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned.
You will contribute by:
Providing Data Management leadership across assigned trial(s) acting as the Trial Data Manager where needed
Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes.
Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
Performs Data Management activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
Manage local lab set up for the Clinical Database as applicable
Performs Data Management hands on activities during the study
Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation
Supports and assists Junior staff for assigned trial
Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
Provides effective input into DM initiatives and innovations for quality, efficiency, and continuous improvement in scientific and operational excellence
Tracks and reports status and progress for assigned trials, indications, or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
Ensures adherence to GCP, Data Management standards, SOPs/WPS and process guidelines
(minimum/desirable): University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree.
Languages: Fluent English (oral and written).
Ability to work under pressure demonstrating agility through effective and innovative team leadership
Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
Excellent problem-solving skills
Ideally 4 years’ experience in Drug Development with at least 3 years' in Clinical Data Management
Excellent verbal and written skills.
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