Sr. Clinical Trial Associate (Hybrid - Acton, MA)

Insulet Corporation•San Diego, MA

2d•Hybrid

About The Position

The Associate Project Manager (APM) supports the planning, execution, and delivery of medical device clinical trials and clinical initiatives under the guidance of a Clinical Project Manager. This role is responsible for coordinating cross‑functional activities, maintaining project plans, tracking timelines and budgets, and ensuring operational alignment across Clinical Affairs, Regulatory, Quality, and external partners. The APM serves as a key connector between trial operations (e.g., Clinical Trial Associates, CROs, vendors, clinical sites) and project leadership, enabling effective execution, issue management, and communication. This role requires strong organizational, analytical, and interpersonal skills, with increasing responsibility for independent project ownership over defined workstreams or smaller studies. The APM ensures clinical trial activities are conducted in compliance with applicable regulations (e.g., FDA, ISO 14155, ICH‑GCP), company SOPs, and study‑specific requirements. In addition to hands‑on trial execution, the APM may contribute to process improvement initiatives, vendor oversight, inspection readiness, and departmental operational excellence.

Requirements

Bachelor’s degree in life sciences, healthcare, engineering, or a related discipline (or equivalent combination of education and experience).
Minimum 3–5 years of experience in clinical research, clinical operations, or clinical project coordination within a medical device, pharmaceutical, or biotechnology environment.
Experience supporting regulated clinical trials and working cross‑functionally with internal stakeholders and external vendors.
Prior exposure to project management methodologies or tools preferred.
Strong understanding of clinical trial operations and applicable regulations (e.g., FDA, ISO 14155, ICH‑GCP).
Solid project coordination and organizational skills with the ability to manage multiple priorities in parallel.
Excellent written and verbal communication skills, including the ability to prepare clear project updates and documentation.
Analytical mindset with attention to detail and proactive problem‑solving abilities.
Ability to work collaboratively across functions and influence without direct authority.
Proficiency with project management tools, trackers, and clinical systems (eTMF, CTMS, document repositories); strong PC skills including Excel and Word.
Adaptable, accountable, and effective in a fast‑paced, regulated environment

Responsibilities

Clinical Project Planning & Execution Support: Clinical Project Planning & Execution Support Clinical Project Managers in the planning and execution of domestic and international medical device clinical trials. Develop, maintain, and update clinical project plans, timelines, and trackers; monitor progress against milestones and escalate risks or delays as appropriate. Coordinate clinical trial start‑up, maintenance, and closeout activities across internal teams and external partners. Support feasibility assessments, study resourcing plans, and operational readiness activities.
Project Coordination & Communication: Serve as a central point of coordination for cross‑functional clinical activities, ensuring alignment among Clinical Affairs, Regulatory, Quality, Data Management, and vendors. Prepare meeting agendas, project materials, and status reports; document decisions, action items, and follow‑up activities. Facilitate effective communication between project stakeholders, ensuring timely flow of information and issue resolution.
Budget, Vendor & Resource Support: Support development, tracking, and maintenance of clinical trial budgets in collaboration with Clinical Project Management and Finance. Track project‑level financials, including purchase orders, invoices, forecasts, and spend vs. budget. Support oversight of CROs and vendors by tracking deliverables, timelines, and compliance with contractual and project requirements.
Risk, Issue & Change Management: Assist with identification, documentation, and tracking of project risks, issues, and mitigation plans. Support impact assessments for protocol amendments, scope changes, and operational changes. Escalate project concerns proactively with recommended options for resolution.
Documentation, Quality & Compliance: Ensure project documentation is maintained in accordance with SOPs, regulatory requirements, and inspection readiness standards. Support TMF oversight activities in partnership with Clinical Trial Associates and Project Managers. Contribute to audit and inspection readiness by supporting responses, documentation retrieval, and corrective action tracking.
Continuous Improvement & Leadership Development: Support development and improvement of clinical project management tools, templates, and processes. Contribute to SOP development, training initiatives, and implementation of best practices across Clinical Affairs. Provide functional guidance to Clinical Trial Coordinators or Clinical Trial Associates on project‑related deliverables, as appropriate. Build foundational project management competencies in preparation for progression to Clinical Project Manager.