About The Position

The Future Talent Program offers internships lasting up to 12 weeks, including one or more projects. These opportunities within our Research Lab Division provide development and a chance to assess long-term career fit. The Trial Manager is responsible for creating and ensuring the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. This involves developing and managing project plans from protocol development through database lock, archiving, and submission deliverables. Collaboration with appropriate functional areas ensures resource alignment and timely, quality execution of project plans. The role involves agreeing/arbitrating deliverable-based commitments based on trial complexity and requirements, managing change, customer, and stakeholder expectations, facilitating cross-functional decision-making, and performing risk management. The position represents Global Data Management on cross-functional trial teams and in development forums. Under guidance, may serve as a data management lead or support role for filing programs. Participation in the development of and adherence to clinical data management procedures is required. Interaction with staff across sites, countries, and time zones is expected.

Requirements

  • 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 2027.
  • Candidates must have interest in learning Clinical Data Management.

Nice To Haves

  • Basic understanding of the clinical research process for Clinical Data Management lifecycle.
  • Familiar and comfortable with database concepts and tools to manage, extract, and report data.
  • Strong organization, leadership, and management skills.
  • Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.

Responsibilities

  • Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials, including case report form (CRF) data, lab data, external data, biomarker data, and clinical outcomes assessments.
  • Serves as project manager for all clinical data management activities for assigned trials.
  • Uses interpersonal, negotiating, and project management skills to perform and manage project planning, initiation, execution, change control, and closing.
  • Manages project team development, leadership, meeting management, and resource coordination.
  • Conducts risk management planning, including risk identification, analysis, response planning, monitoring, and control, with escalation as necessary.
  • Manages customer/stakeholder expectations and facilitates cross-functional decisions.
  • Defines trial-level requirements for quality data collection and validation.
  • Reads and interprets clinical protocols from a clinical data management perspective.
  • Provides clinical data management input into trial design, ensuring operational feasibility.
  • Engages with stakeholders and subject matter experts to assess complexity, define data management requirements and inputs, and confirm deliverables and services.
  • Ensures appropriate use of standards and project-level consistency in database design, data collection, and validation.
  • Facilitates assessment and processing of standards and change requests.
  • Approves trial-level data validation plans.
  • Manages trial-level data quality and completion of database lock and post-database lock activities.
  • Monitors the overall status and quality of data collected during the in-life portion of a trial.
  • Engages with stakeholders and subject matter experts to refine data management tools and validation plans.
  • Ensures activities required to achieve database lock (or data extraction) are completed by appropriate functional areas.
  • Ensures timely archival of trial data and documentation.
  • Ensures timely decommissioning of clinical data management technologies.
  • Accountable for ensuring the successful execution of delivery of data management services provided by external partners for outsourced trials.
  • Supports site and sponsor audits.
  • Identifies and supports improvements to data collection and data management processes and tools.

Benefits

  • Equal Employment Opportunity Employer
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