Join our team as a Specialists in Clinical Data Management to support our clinical studies. In this role, as a Clinical Data Management Specialist, you’ll assumes the responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.

Primary activities include, but are not limited to:

Coordinates and participates in the following activities:

• Design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.
• Review the technical feasibility of study team proposed programming/reporting and technically implement them. Work effectively among teams to communicate issues and ideas to improve business along with understanding of Protocol.
• Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
• Perform ongoing support for In-Life Reports.
• Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
• Participate in extra activities including, but not limited to, study improvement task forces, automation, initiatives, testing of new systems, and ongoing training and mentoring.

Power BI Operations Management Automation Innovation Compassion Databricks Multitasking Communication Data Analysis SAS (Software) Data Cleansing Drug Discovery Clinical Trials FDA Regulations Problem Solving Data Management Change Requests Telephone Skills Data Engineering Clinical Research Microsoft Windows Incident Reporting Clinical Monitoring Contingent Workforce Lifecycle Management Computer Programming Data Quality Assurance Artificial Intelligence Pre-Clinical Development Clinical Data Management SQL (Programming Language) Document-Oriented Databases Python (Programming Language) Electronic Data Capture (EDC) Structured Query Language Procedural Language (SQL PL), * Associate degree with a minimum of 3 years’ experience working in clinical data programming, data engineering, or related data-management/clinical operations functions OR

• Bachelor’s Degree with a minimum of 2 years’ experience working in in clinical data programming, data engineering, or related data-management/clinical operations functions OR
• Advanced Degree (master’s or doctorate) with prior experience in clinical development and / or clinical data programming, data engineering, or related data-management/clinical operations activities preferred.

Required Knowledge and Skills:

• Strong technical proficiency in Clinical Data Management/Reporting Systems like Databricks, Python, SAS, SQL/PL SQL, Power BI, etc along with AI related tools.
• Solid knowledge of MS Windows/Office software and exposure to web-based applications.
• Solid knowledge of System Development Lifecycle Management / system validation knowledge.
• Ability to establish and maintain good working relationships with different functional areas.
• Strong sense of urgency and customer focus.
• Excellent communication skills and interacts effectively with Study Team.
• Strong organizational and problem-solving skills.
• Desire and ability to learn new processes and technologies.
• Ability to multi-task, work independently, and good communication skills.
• Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH.

eligibleforERP

#clinicaltrialjobs

GDMS, Clinical Data Management, Communication, Computer Programming, Data Analysis, Data Management, Data Quality Assurance, Electronic Data Capture (EDC), PL/SQL (Programming Language), SQL Databases, Team Communication, Management

Automation Innovation Compassion Databricks Multitasking Communication Data Analysis SAS (Software) Data Cleansing Drug Discovery Clinical Trials FDA Regulations Problem Solving Data Management Change Requests Telephone Skills Data Engineering Clinical Research Microsoft Windows Incident Reporting Clinical Monitoring Contingent Workforce Lifecycle Management Computer Programming Data Quality Assurance Artificial Intelligence Pre-Clinical Development Clinical Data Management SQL (Programming Language) Document-Oriented Databases Python (Programming Language) Electronic Data Capture (EDC) Structured Query Language Procedural Language (SQL PL) +0

Google IT Automation with Python, Veeva PL/SQL Power BI Operations Management Automation Innovation Compassion Databricks Multitasking Communication Data Analysis SAS (Software) Data Cleansing Drug Discovery Clinical Trials FDA Regulations Problem Solving Data Management Change Requests Telephone Skills Data Engineering Clinical Research Microsoft Windows Incident Reporting Clinical Monitoring Contingent Workforce Lifecycle Management Computer Programming Data Quality Assurance Artificial Intelligence Pre-Clinical Development Clinical Data Management SQL (Programming Language) Document-Oriented Databases Python (Programming Language) Electronic Data Capture (EDC) Structured Query Language Procedural Language (SQL PL) +0

Google IT Automation with Python

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The salary range for this role is $87,300.00 - $137,400.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.