Study Delivery Associate

Role Description:

The Study Delivery Associate provides essential administrative and operational support to clinical trial management activities. This role supports the Study Delivery Team in meeting study timelines, ensuring regulatory compliance, and executing standardized processes related to clinical trial coordination, document and system management. The Associate may also contribute to SSU Hub activities to promote expertise, quality, and consistency across studies. Key responsibilities include maintaining accurate and timely data within clinical systems (e.g., CTMS) and supporting study training and related operational requirements.

Roles & Responsibilities:

Study Planning & Coordination

• Support and sometimes own the development and maintenance of study-level trackers, dashboards, timelines, and tools (e.g., vendor management, sample tracking, drug supply planning) to ensure accuracy and visibility.
• Coordinate and deliver logistics for investigator meetings, trial-related events, and site communications.
• Manage assigned start-up activities, including system setup, access management, and document readiness, ensuring completion to required standards.

Study Execution & Oversight

• Use study dashboards and reports to monitor global enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.
• Lead delivery of assigned risk-based quality management (RBQM) activities, such as risk assessments, mitigation planning, and monitoring plan inputs, including facilitation of team discussions where needed.
• Track and report study progress, coordinating with Study Delivery Managers and vendors to resolve operational issues and maintain compliance.
• Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.

Stakeholder Engagement & Team Collaboration

• Build and maintain effective relationships with internal study team members, vendors and investigator sites
• Act as a reliable point of contact for routine study updates, ensuring stakeholders are informed and aligned.
• Identify, prioritize, and escalate risks effectively to support swift, informed decisions

Site & Vendor Engagement

• Coordinate with vendors and suppliers to ensure quality, speed, and consistency in deliverables.

Data & Systems Management

• Maintain and monitor clinical trial systems (e.g., CTMS), ensuring accurate and timely data entry and reporting.
• Support data collection oversight, including query resolution and reconciliation activities.
• Manage trial documentation (e.g., TMF) to ensure inspection readiness.

Process Improvement & Knowledge Sharing

• Contribute to best practice development, knowledge-sharing and process improvement within the study support community.
• Proactively identify and highlight opportunities to streamline / automate activities within remit.
• Support CAPA processes and embed lessons learned across studies.

Basic Qualifications and Experience:

• Bachelors degree OR
• Associates degree and 4 years of clinical execution experience OR
• High school diploma / GED and 6 years of clinical execution experience

Preferred Qualifications and Experience:

2 years'' work experience in life sciences or medically related field, including 1 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO companyExperience working on global clinical trials

Competencies:

• Expertise in clinical trial processes, operations, and oversight in biotech, pharmaceutical, or Contract Research Organization environments
• Strong skills in using MS Word, Excel, PowerPoint, and other relevant software for documentation, data management, and trial support
• Experience with tracking and filing of essential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents are version-controlled and inspection-ready.
• Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools. Ability to maintain accurate and timely data entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance
• Cultural sensitivity and collaboration across global teams.
• Ability to recognize, highlight and resolve issues. Demonstrates curiosity and willingness to take on new tasks.