Merck & Co.-posted 3 months ago
$39,600 - $105,500/Yr
Full-time • Intern
Rahway, NJ
Chemical Manufacturing

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research & Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals. Our clinical team is recruiting for summer interns within the trial manager area of our company. The Trial Data Manager: Creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents Global Data Management on cross-functional trial teams and in other trial-level development forums. Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our Company clinical data management procedures. Interacts with staff across multiple our Company sites.

  • Develop detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug/vaccine program.
  • Serve as project manager of all clinical data management activities for trials as assigned.
  • Project planning, initiation, execution, change control, and closing.
  • Project team development, project team leadership, meeting management, and resource coordination.
  • Risk management planning including risk identification, analysis, response planning, monitoring, and control.
  • Management of customer/stakeholder expectations; facilitation of cross-functional decisions.
  • Defines trial-level requirements for quality data collection and validation at the trial level.
  • Read and interpret the clinical protocol from a clinical data management perspective.
  • Provide clinical data management input into trial design, ensuring operational feasibility.
  • Engage with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs, and confirm all data management deliverables and services required for a trial.
  • Ensure appropriate use of standards and project-level consistency of database design, data collection, and validation.
  • Facilitate assessment and processing of standards and change requests.
  • Approve trial-level data validation plan.
  • Manage trial-level data quality and completion of database lock and post-database lock activities.
  • Monitor overall status and quality of data being collected during the in-life portion of a trial.
  • Engage with key stakeholders and subject matter experts to refine data management tools and validation plans.
  • Ensure activities required to achieve database lock are completed by appropriate, responsible functional area.
  • Ensure timely archival of trial data and documentation.
  • Ensure timely admission of clinical data management technologies.
  • Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials.
  • Support site and sponsor audits, as appropriate.
  • Identify and support improvements to data collection and data management processes and tools.
  • Candidate must be working towards completion of a B.A. or B.S. degree in life sciences, computer science or related discipline.
  • Candidates must be available to work full-time for up to twelve (12) weeks beginning June 2025.
  • Candidates must have interest in learning Clinical Data Management.
  • Basic understanding of the clinical research process.
  • Strong organization and management skills.
  • Ability to communicate effectively (verbal and written), within technical and business areas.
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