Associate Specialist, Clinical Data Management, Hybrid

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.

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 (GCDM), Clinical Research (CR) and Global Safety (GS). Review the technical feasibility of study team proposed programming/reporting and technically implements them. Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol .
• 3Support 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, automations, initiatives, testing of new systems, and ongoing training and mentoring.

• B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience., * Expected to have a good technical proficiency in a Clinical Data Management/Reporting Systems like PowerBI or SQL/PL SQL or Databricks or Python or SAS, 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.
• Possesses excellent communication skills and interacts effectively with Study Team along with 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, Food and Drug Administration (FDA) regulations, Good (anything) Practices (GxP) guidelines, International Council for Harmonisation (ICH), Adaptability, Analytical Problem Solving, Clinical Data Management, Computer Science, Data Analysis, FDA Regulations, Good Clinical Practice (GCP), Multitasking, Systems Development Lifecycle (SDLC), Teamwork, Working Independently

Preferred Skills:

Clinical Studies, Group Problem Solving, Java (Programming Language), Science

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The salary range for this role is

$71,900.00 - $113,200.00

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.