Manager II, Clinical Studies

Alkeus Pharmaceuticals • Cambridge, MA

3d • $120,000 - $168,000

About The Position

The Manager II, Clinical Studies provides strategic and operational leadership for assigned clinical studies, from planning and start-up through execution, database lock, closeout, and archival. The role is accountable for operational delivery of studies, including achievement of timelines, budgets, quality standards, and study objectives. It works closely with Clinical Development, Clinical Science, Data Management, Biostatistics, Regulatory Affairs, Drug Safety, Quality Assurance, Clinical Supply, and other functions to support coordinated, compliant study execution under applicable regulatory requirements, Good Clinical Practice (GCP), company procedures, and study protocols.

The position also provides operational oversight of CROs, vendors, investigative sites, and study teams; monitors study performance, risks, budgets, and milestones; and supports quality, inspection readiness, and continuous improvement in Clinical Operations.

Requirements

• Bachelor’s degree in a scientific, healthcare, nursing, pharmacy, or related discipline.
• At least 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 CROs and vendors.
• Experience managing clinical studies from start-up and site management through enrollment strategies, database lock, and closeout.
• Experience managing study budgets and vendor contracts.
• Prior experience supporting regulatory inspections and audit readiness.
• Ability to travel up to 20% of the time, as needed.
• Highly organized and detail-oriented, with a focus on delivering quality results.
• Excellent verbal and written communication skills, including translating complex concepts for varied audiences.
• Demonstrated intellectual curiosity, innovation, and creative problem-solving.
• Ability to lead fast-paced projects with urgency and deliver work well.
• Hands-on experience and expertise.
• Successful record as a team player and collaborator in small working environments.
• High standards of professionalism, confidence, personal values, and ethics.
• Entrepreneurial spirit and passion for building, learning, and evolving with the team.

Nice To Haves

• Advanced degree (MS, PhD, or PharmD).
• Rare disease experience.
• Ophthalmology experience.

Responsibilities

• Lead operational planning, implementation, and execution of assigned clinical studies from feasibility and start-up through database lock, closeout, and archival.
• Support and maintain integrated study timelines, management plans, operational strategies, risk assessments, decision logs, and study metrics.
• Drive study milestones and deliverables, including site activation, enrollment, data collection, monitoring, database lock, and closeout.
• Monitor study performance and proactively identify risks involving timelines, enrollment, budget, quality, data, vendors, sites, and resources; develop mitigation and contingency plans.
• Lead resolution of complex study issues and escalate significant risks or decisions to Clinical Operations leadership and governance forums.
• Provide study status, risk, budget, and milestone updates to program and functional leadership.
• Provide operational oversight of CROs, central laboratories, imaging vendors, technology providers, and other external service providers.
• Participate in CRO and vendor identification, evaluation, selection, contracting, and study start-up activities.
• Monitor CRO and vendor performance against contracts, timelines, budgets, quality requirements, deliverables, and key performance indicators; review study plans, metrics, monitoring reports, documentation, invoices, forecasts, and change orders as appropriate.
• Escalate significant vendor performance concerns and oversee corrective and preventive actions through resolution.
• Oversee site identification, qualification, selection, activation, enrollment, retention, monitoring, and closeout.
• Monitor site performance, enrollment, protocol compliance, data quality, and other study metrics; review monitoring reports and trends for systemic issues and risks.
• Conduct or support co-monitoring and other oversight activities as needed, and maintain effective relationships with investigative sites to resolve operational, recruitment, and protocol-related issues.
• Provide leadership and escalation support to CRAs and study team members on site management and monitoring issues.
• Ensure studies comply with ICH-GCP, applicable FDA, EMA, and local regulatory requirements, company SOPs, approved study plans, and protocols.
• Support internal, CRO/vendor, and investigator-site audits and regulatory inspections; ensure deviations, quality issues, and significant operational risks are documented, assessed, escalated, and resolved.
• Partner with Quality Assurance and other functions on CAPAs and corrective actions; identify documentation gaps and track corrective actions to completion.
• Support review of study budgets, forecasts, accruals, and financial plans with Clinical Operations leadership and Finance as delegated.
• Monitor study expenditures and vendor invoices against approved budgets and contracted scope, and identify opportunities to manage costs while maintaining quality and timelines.
• Contribute to development and continuous improvement of Clinical Operations processes, SOPs, templates, tools, and best practices; capture and implement lessons learned.
• Support departmental initiatives and other related projects as assigned.

Benefits

• Group medical, dental, and vision insurance plans.
• Short- and long-term disability plans.
• Life insurance.
• 401(k) plan.
• Flexible time-off policies.
• Discretionary bonus of up to 15% of base salary, contingent upon meeting performance components.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level