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(Senior) Clinical Data Analyst (Romania, Hungary)

Parexel International Corporation

Romania - Any Region - Home Based

The Functional Service Provider (FSP) division of Parexel is seeking a candidate for a Senior, hands-on Data Manager role. This individual will work with the Clinical Trial Team at a Top 5 Pharma company, behaving as if they are employed directly at this Pharma. The Senior Data Manager will interact directly with the Data Management Team Lead and occasionally with Clinical Project Leaders, Medical Directors, Biostatisticians, Statistical Programmers and Medical Writers. Individuals selected for this role will receive mentoring and oversight support as they transition in experience where they can offer the same to their peers. This opportunity includes oversight for Phase Ib and II Global Oncology studies lasting 2-4 years, allowing full experience from Protocol Review & Database Development through Database Lock. Individuals in this role will gain experience with data deliveries through the life of the trial, including working on submissions to regulatory authorities. QualificationsIdeal candidate will possess: Proven ability to lead and collaborate with global and cross-functional teams - ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role. Ability to independently interact with Sponsor liaison to discuss data issues/project data validation requirements, as needed. Experience and understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards. Experience in clinical research (Pharma/CRO). Bachelor’s degree as a minimum. Excellent interpersonal, verbal and written communication skills. Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG). Robust knowledge of ICH-GCP Guidelines. Good knowledge of EDC systems (e.g. DataLabs, Rave.). Good knowledge of electronic source data capture systems (e.g. ClinBase). Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation. Ability to work in team environment. Fluent English. Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner. Basic knowledge of SAS.

2022-04-22 00:05:31

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