Single Sponsor Clinical Project Manager II (Virology) - 3 days a week in Uxbridge.

Job Responsibilities

• Plan, direct, create, and communicate clinical study timelines to ensure deliverables are produced on schedule, including developing detailed project plans, setting milestones, and coordinating with cross‑functional teams to ensure timely completion of tasks.
• Gather input from cross‑functional teams to create comprehensive plans for clinical studies, collaborating with departments such as regulatory affairs, data management, and clinical operations to integrate their feedback into the study plans.
• Ensure consistency of clinical study processes across clinical trials, adhering to standard operating procedures (SOP), Good Clinical Practice (GCP), and specific country regulations by developing and implementing standardized processes and procedures to ensure uniformity across all trials.
• Oversee and resolve operational aspects of clinical trials in conjunction with project teams, identifying and addressing any issues that arise during the trial, coordinating with team members to implement solutions, and ensuring that the trial stays on track.
• Select sites and vendors, prepare clinical trial budgets, and ensure studies are conducted within clinical trial protocols, evaluating potential sites and vendors, negotiating contracts, and managing budgets to ensure that the trial is conducted within the allocated resources.
• Monitor progress and follow up with team members and line managers when issues develop, tracking the progress of the trial, identifying any deviations from the plan, and working with team members to address any issues that arise.
• Implement and prepare the clinical development strategy as outlined by the clinical teams, developing and executing strategies to achieve the clinical development goals, coordinating with clinical teams to ensure alignment, and monitoring progress towards these goals.
• Develop trial recruitment strategies to ensure successful participant enrollment, identifying target populations, developing recruitment plans, and implementing strategies to attract and retain participants.

Qualifications

• Bachelor’s degree in a related field (e.g., Clinical Research, Life Sciences, Healthcare Management).
• Minimum of 5 years of experience in clinical project management or a related role.
• Proven track record of successfully managing clinical trials and ensuring adherence to SOP, GCP, and country regulations.
• Certification in Clinical Research (e.g., CCRP, CCRA) is preferred.
• Project Management Professional (PMP) certification is a plus.

Necessary Skills

• Strong organizational and planning skills to create and manage clinical study timelines.
• Excellent communication skills to gather input from cross‑functional teams and communicate plans effectively.
• Ability to oversee and resolve operational aspects of clinical trials.
• Knowledge of SOP, GCP, and country regulations to ensure consistency across clinical studies.
• Experience in site and vendor selection, budget preparation, and monitoring progress.
• Ability to implement and prepare clinical development strategies.
• Strong problem‑solving skills to address issues that arise during clinical trials.

Employment is on a full‑time basis. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.