Senior Study Manager – Infectious Disease, Vaccines

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• May lead or assist in conducting one or more studies based on their size and complexity.

• Acts as the main operational contact for trial execution and all associated deliverables.

• Oversees all HQ Operational Activities, which includes establishing, leading, and managing the Clinical Trial Team (CTT).

• Aids in planning for clinical (drug/vaccine) supplies.

• Manages the deployment and collaboration with external vendors (e.g., IVRS, PRO).

• Initiates the planning for Investigator meetings and training on protocols.

• Completes the trial setup and maintains the Clinical Trial Management System (CTMS).

• Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT.

• Initiates planning for recruitment and retention as well as tracking enrollment.

• Responsible for monitoring study-related details (e.g., specimens, queries).

• Oversees training activities for protocols, including training meetings for IMs and CRAs.

• Ensures appropriate postings on investigative site portals.

• Responsible for achieving operational deliverables in preparation for site readiness, country allocation, and recruitment target achievement (with input from others).

• Serves as the escalation point for operational issues related to the study.

• Responsible for operational details during Operational Reviews.

• Creates and maintains the project schedule while collaborating with the Program Lead.

• Establishes and maintains the Trial Master File (eTMF).

• Ensures the budget aligns with protocol requirements.

• Responsible for executing the protocol within the allocated budget.

• Creates and maintains the ADI logs.

• Develops the Site Monitoring Plan (SMP) with input from the monitoring excellence group.

• Develops study-related manuals (e.g., administrative binder, lab manuals).

• Manages activities related to the Emergency Unblinding (EUB) Call Center.

• Co-authors newsletters alongside Clinical Services (CS).

• Approves contracts, invoice payments, and change orders for vendors as necessary.

• Responsible for the reconciliation of study endpoints (clinical and ancillary supplies).

• Oversees all HQ close-out activities.

• Monitors trial activities continuously, including dashboards and tracking.

• Provides support for CS activities as needed to meet CTT deliverables.

• Interfaces with External Data Coordination and Data Management.

• Ensures quality control and readiness for inspections at all times.

• Responsible for assessing risks, as well as planning and executing mitigation strategies.

⛳️ Requirements

• Bachelor’s, Master’s, or Doctorate degree with over 7 years of clinical research experience.

• At least 2 years of experience in the pharmaceutical industry with demonstrated leadership responsibilities required.

• Proven capability to meet demanding timelines.

• Experience with MS Project is preferred.

• Strong skills in Excel and PowerPoint are required.

• Experience in Therapeutic Areas related to infectious diseases and/or vaccines is highly preferred.

• Global experience is necessary.

• Exceptional oral (including presentation) and written communication skills, along with proficiency in computer/database management and project management, are required.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, which may include medical, dental, and vision coverage.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.