Position Summary:The Manager II, Clinical Studies provides strategic and operational leadership for assigned clinical studies from study planning and start-up through execution, database lock, closeout, and archival. The Manager II, Clinical Studies is accountable for the successful operational delivery of assigned studies, ensuring that timelines, budgets, quality standards, and key study objectives are achieved.
Working closely with Clinical Development, Clinical Science, Data Management, Biostatistics, Regulatory Affairs, Drug Safety, Quality Assurance, Clinical Supply, and other functions, the Sr. CSM ensures coordinated and compliant execution of clinical studies in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), company procedures, and study protocols.
Primary Responsibilities:Clinical Study Leadership and Execution- Lead the end-to-end operational planning, implementation, and execution of assigned clinical studies from feasibility and start-up through database lock, closeout, and archival.
- Support development of, and maintain, integrated study timelines, study management plans, operational strategies, risk assessments, decision logs, and study metrics.
- Drive achievement of study milestones and deliverables, including site activation, enrollment, data collection, monitoring, database lock, and study closeout.
- Monitor overall study performance and proactively identify risks related to timelines, enrollment, budget, quality, data, vendors, sites, and resources.
- Develop and implement mitigation and contingency plans to address study risks and operational challenges.
- Lead resolution of complex study issues and escalate significant risks or decisions to Clinical Operations leadership and appropriate governance forums.
- Provide regular study status, risk, budget, and milestone updates to program and functional leadership.
CRO and Vendor Management- Provide operational oversight of CROs, central laboratories, imaging vendors, technology providers, and other external service providers supporting assigned studies.
- Participate in CRO and vendor identification, evaluation, selection, contracting, and study start-up activities.
- Monitor CRO and vendor performance against contractual obligations, timelines, budgets, quality requirements, deliverables, and key performance indicators.
- Review study plans, metrics, monitoring reports, study documentation, invoices, forecasts, and change orders as appropriate.
- Escalate significant vendor performance concerns and oversee corrective and preventive actions through resolution.
Site Management and Study Oversight- Provide leadership and oversight for site identification, qualification, selection, activation, enrollment, retention, monitoring, and closeout.
- Monitor site performance, enrollment, protocol compliance, data quality, and other key study metrics.
- Oversee site qualification, initiation, interim monitoring, and closeout activities.
- Review monitoring reports and trends to identify systemic issues, risks, or areas requiring intervention.
- Conduct or support co-monitoring and other oversight activities, as needed, to assess study quality and monitoring effectiveness.
- Maintain effective relationships with investigative sites and facilitate resolution of operational, recruitment, and protocol-related issues.
- Provide leadership and escalation support to CRAs and study team members regarding site management and monitoring issues.
Regulatory Compliance, Quality and Inspection Readiness- Ensure clinical studies are conducted in accordance with ICH-GCP, applicable FDA, EMA, and local regulatory requirements, company SOPs, approved study plans, and protocols.
- Support internal audits, CRO/vendor audits, investigator-site audits, and regulatory inspections.
- Ensure protocol deviations, quality issues, and significant operational risks are appropriately documented, assessed, escalated, and resolved.
- Partner with Quality Assurance and other functions to oversee CAPAs and other corrective actions, as applicable.
- Identify documentation gaps and ensure corrective actions are implemented and tracked to completion.
Budget and Financial Management- Support review of study budgets, forecasts, accruals, and financial plans in partnership with Clinical Operations leadership and Finance as delegated.
- Monitor study expenditures and vendor invoices against approved budgets and contracted scope.
- Identify opportunities to manage study costs while maintaining quality and timeline requirements.
Clinical Operations Excellence- Contribute to the development and continuous improvement of Clinical Operations processes, SOPs, templates, tools, and best practices.
- Capture and implement lessons learned across studies.
- Support departmental initiatives and other Clinical Operations projects as assigned.
Qualifications:- Education and Certification
- Bachelor's degree in a scientific, healthcare, nursing, pharmacy, or related discipline required
- Advanced degree (MS/PhD/PharmD) is a plus
- Work Experience
- 7+ years of clinical research or clinical operations experience within biotechnology, pharmaceutical, CRO, or related environments
- Demonstrated experience supporting Phase I-III clinical studies
- Strong experience overseeing CRO and vendor oversight
- Experience managing clinical studies from study start-up, site management, enrollment strategies, database lock, to study closeout activities
- Experience managing study budgets and vendor contracts
- Prior experience supporting regulatory inspections and audit readiness
- Rare disease and ophthalmology experience preferred
- Skills and Key Success Factors:
- Entrepreneurship spirit with a passion to build, learn and evolve with the team
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values and ethical standards
Other Relevant Information:- Travel: able to travel up to 20% of time, as needed
- Others: Deliver on other related projects as assigned.
Compensation- Base Salary Range: $120,000 to $168,000, with the actual contingent upon several factors such as the selected candidate's education/work experience/training, and other factors (travel requirements, etc.)
- Discretionary Bonus: up to 15% of Base Salary, contingent upon meeting performance components
- Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.
