Senior Clinical Data Analyst

2 days ago

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Parexel

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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.

Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of proficiency and autonomy. • Further responsibilities shall include providing technical expertise and/or operational leadership regarding all DM operational activities (data cleaning matrices), processes and Data Management documents regarding data validation. • All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements. • SCDA acts as a subject matter expert on DM Systems/processes, providing technical support and expert advice to internal and external sponsors. • The SCDA may act as a back-up to or fulfill the Data Management Lead role where required.

🎯 Requirements

• 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. • Proven negotiation skills and ability to influence in order to achieve mutually beneficial results. • Strong problem-solving skills and logical reasoning, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses. • Commitment to first time quality, including a methodical, analytical and accurate approach to work activities (attention to detail). • Proven Time management and prioritization skills with a strong sense of urgency - in order to meet objectives. • Advanced interpersonal, oral and written communication skills - using concise phrasing tailored for the audience with a diplomatic approach. • Good presentation skills. • Proven learning ability and knowledge sharing approach; swift understanding of technologies and new processes. • A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing technical environments. • Strong sense of accountability relative to Key Accountabilities in Job Description. • Innovative - ability to define strategies to improve efficiency when performing the Data Management tasks. • Written and oral fluency in English. • Advanced understanding of data management processes and data validation flow (e.g. Data cleaning, DB lock). • Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific procedures. • Advanced knowledge of Clinical Data Management Systems and proficiency in at least one system (e.g. InForm, Rave, Veeva, DataLabs, ClinBase). • Good understanding of Clinical Study Team roles within Data Management - awareness of DML activities e.g.: budget reviews, resource forecast, etc. • Experience in clinical research industry. • Advanced knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG). • Advanced knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out. • Advanced knowledge of Database set-up activities, including but not limited to Database Configuration Specifications and setup of Data Validation. • Basic knowledge of SAS (programmed listings). • Basic knowledge of Data standards (CDISC). • Good understanding of financial principles/drivers for management of DM project financials with regards to forecasting and scope of work.