Insulet Corporation
Medical Device
Sr.ClinicalTrialAssociate
“Sr. Clinical Trial Associate at Insulet Corporation. Skills: Clinical trial execution, Project coordination, Regulatory compliance. Support planning and execution of medical device clinical trials. Develop, maintain, and update clinical project plans”
What You'll Achieve.
Ensuring operational alignment; Enabling effective execution; Issue management; Communication; Inspection readiness; Departmental operational excellence
Industry & Context.
Proactive problem-solving abilities; Issue management; Risk management; Mitigation plans; Recommended options for resolution
What They're Looking For.
Must Have
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, Experience working cross‑functionally with internal stakeholders and external vendors, Understanding of clinical trial operations, Understanding of applicable regulations (e.g., FDA, ISO 14155, ICH‑GCP), Solid project coordination and organizational skills, Ability to manage multiple priorities in parallel, Excellent written and verbal communication skills, Analytical mindset, Attention to detail, Proactive problem-solving abilities, Ability to work collaboratively across functions, Proficiency with project management tools, trackers, and clinical systems (eTMF, CTMS, document repositories), PC skills including Excel and Word, Adaptable, accountable, and effective in a fast-paced, regulated environment
Nice to Have
Prior exposure to project management methodologies or tools
What You'll Do.
Support planning and execution of medical device clinical trials
and update clinical project plans
Monitor progress against milestones
Escalate risks or delays
Coordinate clinical trial start-up
and closeout activities
Support feasibility assessments
Support study resourcing plans
Support operational readiness activities
Serve as a central point of coordination for cross-functional clinical activities
Ensure alignment among Clinical Affairs
Prepare meeting agendas
Facilitate effective communication between project stakeholders
and maintenance of clinical trial budgets
Track project-level financials
Support oversight of CROs and vendors
Assist with identification
and tracking of project risks
Support impact assessments for protocol amendments
and operational changes
Escalate project concerns proactively
Ensure project documentation is maintained in accordance with SOPs
regulatory requirements
and inspection readiness standards
Support TMF oversight activities
Contribute to audit and inspection readiness
Support development and improvement of clinical project management tools
Contribute to SOP development
and implementation of best practices
Provide functional guidance to Clinical Trial Coordinators or Clinical Trial Associates
Build foundational project management competencies
How You'll Work.
Team & Collaboration
Coordinating cross‑functional activities; Ensuring operational alignment across Clinical Affairs, Regulatory, Quality, and external partners; Serving as a key connector between trial operations and project leadership; Working cross‑functionally with internal stakeholders and external vendors; Working collaboratively across functions; Ensuring alignment among Clinical Affairs, Regulatory, Quality, Data Management, and vendors; Facilitating effective communication between project stakeholders; Providing functional guidance to Clinical Trial Coordinators or Clinical Trial Associates
Communication Scope
Excellent written and verbal communication skills; Ability to prepare clear project updates and documentation
Process & Methodology
Clinical Project Planning & Execution, Develop, maintain, and update clinical project plans, Monitor progress against milestones, Coordinate clinical trial start-up, maintenance, and closeout activities, Project Coordination & Communication, Budget, Vendor & Resource Support, Risk, Issue & Change Management, Documentation, Quality & Compliance, Continuous Improvement & Leadership Development, Project management methodologies, Project management tools, Trackers, Clinical systems
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