Job Description

Job Title: Sr. Clinical Operations Consultant (Manager)

Location: Malvern, PA

The Work

• Clinical Ops Strategist and Executioner.
• They have a BLA that is due Q1 of 2026 and they have to hit this deadline.
• They need to recruit 150 patients and this role must strategize around this and roll up their sleeves.
• Provide leadership role in conducting multiple Phase I-IV clinical research trials across all functional areas of the drug development process
• Ensure adherence to CRO/Vendor oversight procedures and governance that are used across all programs
• Oversee and coordinate the operations aspects of assigned projects and project teams
• Lead the selection and negotiation activities related to CROs, vendors and investigator sites as it relates to contracts, work orders and budgets
• Review budgets, forecasts and accruals for assigned clinical studies, and ensure that clinical projects remain on schedule and within budget
• Responsible for determining and communicating to CMO/Executive Management adequate resource requirements
• Be accountable for study execution and report on study progress, timelines, milestones, and challenges
• Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings, as required
• Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed
• Maintain strong relationships with Principal Investigators (PI) and study personnel
• Hire, develop and retain clinical operations staff as needed
• Additional tasks and projects as requested

Qualifications

• Bachelor’s degree required; advanced degree preferred
• 10+ years of relevant industry experience in clinical/medical research or biotech/pharma; Vaccine product development expertise preferred
• 7+ years leading Clinical Operations, 3 years in a small to mid-size company
• Comprehensive understanding of applicable clinical research regulations in multiple regions
• Demonstrated management and cross-functional collaboration skills with proven experience to drive productivity, efficiency, and quality
• Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment
• Understand and experience in data management, statistics, and project management necessary for successful study execution
• Advanced understanding of clinical development
• Ability to set priorities, direct multiple projects and implement complex strategies
• Excellent analytical and problem-solving skills
• Proven negotiating experience with internal and external stakeholders

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