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