Clinical Operations Lead
Excelya
full-time
Posted on:
Location Type: Hybrid
Location: Swiftwater • Pennsylvania • United States
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Job Level
Tech Stack
About the role
- Coordinate and support clinical project teams, including identification and alignment of Clinical sub-team members
- Actively contribute to project and clinical team meetings, ensuring effective follow-up and communication
- Coordinate Clinical sub-team meetings and ensure action tracking and issue resolution
- Lead coordination of Clinical CTD task forces and contribute to PAI preparation, conduct, and closure
- Collaborate closely with GCDSE on project execution, team organization, and governance
- Ensure clear team direction, alignment with franchise and project strategy, timeline adherence, and proactive risk and escalation management
- Contribute to clinical operational strategy documents (e.g. TPP, CDP)
- Use clinical project analytics to identify, monitor, and communicate risks, issues, and alerts
- Ensure timely and accurate planning and reporting, including project plans, timelines, budgets, and operational updates
- Support platform and organizational initiatives by contributing to process improvement, acting as a subject matter expert, and delivering training related to job certification
Requirements
- At least 5 years of experience in clinical operations as project manager within a CRO or pharmaceutical environment, including prior leadership responsibilities.
- In-depth knowledge of clinical trial methodologies, regulatory standards, and GCP; exceptional leadership and communication skills with the ability to foster positive relationships.
- Master’s degree in life sciences or a related field; advanced degree is preferred.
- Fluent in English; proficiency in additional languages is a plus.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical project managementclinical trial methodologiesregulatory standardsGCPproject analyticsrisk managementbudget planningtimeline adherenceprocess improvementtraining delivery
Soft Skills
leadershipcommunicationrelationship buildingteam coordinationissue resolutionproactive managementcollaborationorganizational skillseffective follow-upalignment facilitation