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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.

Senior Clinical Data Analyst

Job ID 66153BR Mexico - Any Region - Home Based

The 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.

Qualifications

Personal skills that include:
o Good interpersonal, oral and written communication skills
o Excellent learning ability
o Ability to work effectively with virtual teams
o Work with integrity
o Good analytical skills ad attention to detail
o Proven problem solving skills
o Ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
o Effective time management in order to meet team objectives, and completion of tasks in a timely manner
o Ability to gain trust and confidence with a variety of clients as well as within PAREXEL
• Business / Operational skills that include:
o Strong customer focus, ability to interact professionally within a client organization
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Good knowledge of EDC systems (e.g. DataLabs, InForm, Rave)
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
o Good technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS
Good knowledge of all DB set-up activities including but not limited to Database Configuration Specifications, Data Validation
o Basic knowledge of SAS

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