Study Delivery Sr Associate

Role Description:

The Study Delivery Senior Associate provides essential global operational support to clinical study teams, ensuringtimely, high-quality, and compliant study execution. They complete assignedby the Study Managers and Leadsstart-up and conduct activities, own specific study tasks,support withmonitoringforrisks or issues, and escalate early warning signals with proposed solutions to relevant stakeholders.

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.

• Coordinatelogisticsfor investigator meetings, trialevents, and site communications.

• Manage assigned start-upactivities, including system setup, access management, and document readiness, ensuring completiontorequired standards.

Study Execution & Oversight

• Use study dashboards and reports tomonitorglobal enrollment, data flow, and quality indicators, taking proactive action to address deviations and risks.

• Lead delivery of assignedrisk andqualitymanagementactivities

• Track and report study progress, coordinating with Studyteamand vendors to resolve operational issues andmaintaincompliance.

• Deliver assigned components of global recruitment and retention strategies to help ensure enrollment targets are achieved.

Stakeholder Engagement & Team Collaboration

• Build andmaintaineffective relationships with internal study team members,vendorsand investigator sites

• Act as a 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 andmonitorclinical trial systems (e.g., CTMS), ensuringaccurateandtimelydata entry and reporting.

• Support data collection oversight, including query resolution and reconciliation activities.

• Manage trial documentation (e.g., TMF) to ensureinspectionreadiness.

Process Improvement & Knowledge Sharing

• Contribute to best practice development, knowledge-sharingand process improvement within the study support community.

• Proactivelyidentifyand highlight opportunities to streamline / automate activities within remit.

• SupportCorrective and Preventive Actions(CAPA)processes and embed lessons learned across studies.

Basic Qualifications and Experience:

• Masters degree OR

• Bachelors degree and 2 years of clinical execution experience OR

• Associates degree and 6 years of clinical execution experience OR

• High school diploma / GED and 8 years of clinical execution experience

PreferredQualifications and Experience:

• 3yearswork experience in life sciences or medically related field, including 1yearsof biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company

• Experience working on global clinical trials

Competencies

• Understandsimportanceof accuracy in documentation, data tracking, and compliance checks.Identifiesdiscrepancies and escalates appropriately.

• Expertisein 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

• Working knowledge of CTMS, eTMF, EDC, and Microsoft Office tools.Ability tomaintainaccurateandtimelydata entry. Skilled in managing clinical trial data flow, investigator documentation, and protocol adherence while ensuring regulatory compliance

• Experience with overseeing vendors

• Experience executing risk-based site monitoring, Corrective and Preventive Actions (CAPA) implementation, and risk mitigation to resolve operational challenges and ensure inspection readiness

• Cultural sensitivity and collaboration across global teams.

• Abilityto recognize,highlightand resolve issues.Demonstrates curiosity and willingness to take on new tasks.

• Understanding of the clinical and pharmaceutical drug development process and clinical trial execution principles

• Experience withtracking andfiling ofessential documents such as protocols, informed consent forms, and regulatory submissions to ensure documents areversion-controlled and inspection-ready.