Associate Clinical Project Manager - Sponsor Dedicated in Reading

The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing, and reporting of assigned studies in compliance with Sponsor processes and regulatory requirements. The CPM is the single point of contact and study team lead for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Leads and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies. The CPM collaborates with various managers in the planning, execution, and delivery of their assigned studies.

Responsibilities:

• Supports SSO Study Start-up Manager with the development of country/cluster/hub study execution plans and timeline commitments.
• Participates with the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time.
• Proactively identifies risks and opportunities for the assigned studies and develops respective mitigation plans.
• Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel.
• Drives the conduct of the study to ensure all study operational aspects are on track.
• Ensures recruitment targets are met and reviews enrollment at the site level.
• Responsible for setting up contingency plans to ensure recruitment targets are achieved.
• Oversees local study team activities to achieve study timelines and quality execution.
• Leads/chairs country/cluster/hub study team meetings and participates in global clinical trial team meetings.
• Maintains oversight of country/cluster/hub level data management activities.
• Coordinates the study handover process with CRAs and their managers.
• Tracks all study close-out activities and ensures they are performed in a timely manner.
• Conducts or coordinates training for CRAs to support site readiness to recruit and study execution.
• Evaluates potential challenges/risks in the protocol and operational aspects of the study.
• Accountable for monitoring quality and issue resolution through timely review and approval of study monitoring visit reports.
• Promotes a compliance culture advocating adherence to highest standards and ethical integrity.
• Acts as the escalation point for issues in monitoring visit reports for the assigned studies.
• Communicates with CRAs and their managers to ensure issue resolution in a timely manner.
• Supports inspection readiness and submission preparation for monitoring-related activities.
• Monitors the status of site budget and contract negotiations.
• Tracks study budget with appropriate study budget in responsible Country.
• Ensures timely TCF preparation and submission.
• Processes invoiceable items for site level clinical study activities.
• Serves as core member of the Global Clinical Trial team as a Country and Hub representative.
• Interfaces with SSU teams to ensure on-time initiation of all sites within geography.
• Interfaces with Country study execution teams to ensure on-time recruitment, data delivery, and study close out.

Requirements:

• Bachelor's Degree in Life sciences or related field.
• 5 years of prior relevant experience including > 1 year project management experience.
• Advanced knowledge of job area and broad knowledge of other related job areas.
• Knowledge of clinical trials and applicable clinical research regulatory requirements.
• Strong written and verbal communication skills including good command of English language.
• Strong problem solving skills.
• Ability to work through others to deliver results.
• Planning, time management and prioritisation skills.
• Attention to detail and accuracy in work.
• Good software and computer skills, including MS Office applications.
• Ability to establish and maintain effective working relationships.
• Good understanding of project financials.