This posting is intended for the Hiring Our Heroes, Corporate Fellowship Program. Only those US active military members registered with Hiring Our Heroes should apply.

The Clinical Data Management (CDM) fellowship is responsible for activities pertaining to end-to-end data management of clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to:

• Performs data entry following relevant guidelines.
• Runs data integrity check reports in accordance with data review plan and relevant SOPs.
• Completes trial level archiving activities including, but not limited to, filing of essential documentation.
• Supports inspection readiness via ongoing reconciliation of essential documents.
• Supports other document management tasks (via MS Office).
• May support other CDM tasks as necessary.
• Creation and management of Paper Case Report Form (CRF) inventory tool. ·
• Escalations of overdue items, including outstanding questions and missing visits.
• Review of basic standard reports.
• Quality Control of Data Review Plan (DRP) and report run package.
• Participates in the development and implementation of change request activities.
• Raises questions to, reviews responses from, and corresponds with stakeholders and customers.
• Completes user acceptance testing of data management tools.
• Completes assigned data management activities in support of database lock.
• Maintains compliance with standard key performance indicators.
• Monitors data quality and cycle-time performance measures, performs root cause analysis and implements action plans.
• Proactively communicates with team members to share project status, risk assessment and outstanding item resolution status.
• Supports training and mentoring as needed (includes creation and updates of training content).

Education and Experience:

• High School Diploma (or equivalent).

Requirements:

• Basic knowledge of MS Office – Word/Excel/Outlook
• Experience working with sensitive/confidential documents preferred
• Proven work experience preferred

Primary Work Site/Schedule

• Hybrid: Monday-Thursday (9:00am – 5:00pm US Eastern Time), Rahway, NJ or West Point, PA (Preference)

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Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Requisition ID:P-100629