Manager II, Clinical Studies

Alkeus Pharmaceuticals • Cambridge, MA

2d

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, including achievement of study timelines, budgets, quality standards, and objectives. The position collaborates with Clinical Development, Clinical Science, Data Management, Biostatistics, Regulatory Affairs, Drug Safety, Quality Assurance, Clinical Supply, and other functions to ensure coordinated and compliant study conduct under applicable regulatory requirements, Good Clinical Practice, company procedures, and study protocols.

The position also oversees CROs, vendors, and clinical sites; monitors study performance, risks, budgets, and quality; supports regulatory compliance and inspection readiness; and contributes to improvements in Clinical Operations processes and practices. Travel may be required up to 20% of the time. Other related projects may be assigned.

Requirements

• Bachelor’s degree in a scientific, healthcare, nursing, pharmacy, or related discipline.
• At least 7 years of clinical research or clinical operations experience in 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.
• Highly organized and detail-oriented, with a focus on delivering quality results.
• Excellent verbal and written communication skills, including the ability to translate complex concepts for varied audiences.
• Ability to lead fast-paced projects with urgency and deliver work effectively.
• Hands-on experience and expertise.
• Successful record as a team player and collaborator in small working environments.
• Professionalism, confidence, strong personal values, and ethical standards.
• Able to travel up to 20% of the time, as needed.

Nice To Haves

• Advanced degree (MS, PhD, or PharmD).
• Rare disease experience.
• Ophthalmology experience.
• Entrepreneurial spirit and passion for building, learning, and evolving with a team.
• Intellectual curiosity, innovation, and creative problem-solving.

Responsibilities

• Lead operational planning, implementation, and execution of assigned studies from feasibility and start-up through database lock, closeout, and archival.
• Support development and maintenance of integrated study timelines, management plans, operational strategies, risk assessments, decision logs, and metrics.
• Drive study milestones and deliverables, including site activation, enrollment, data collection, monitoring, database lock, and closeout.
• Monitor study performance and 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.
• Oversee 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.
• Monitor vendor performance against contracts, timelines, budgets, quality requirements, deliverables, and key performance indicators; review plans, metrics, reports, documentation, invoices, forecasts, and change orders as appropriate.
• Escalate significant vendor performance concerns and oversee corrective and preventive actions through resolution.
• Lead and oversee site identification, qualification, selection, activation, enrollment, retention, monitoring, and closeout.
• Monitor site performance, enrollment, protocol compliance, data quality, and other study metrics; oversee site qualification, initiation, interim monitoring, and closeout activities.
• Review monitoring reports and trends, conduct or support co-monitoring and oversight activities, and address systemic issues or risks.
• Maintain 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 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 protocol deviations, quality issues, and significant operational risks are documented, assessed, escalated, and resolved; partner with Quality Assurance on CAPAs and other corrective actions.
• Identify documentation gaps and ensure corrective actions are implemented and tracked 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 cost-management opportunities that preserve quality and timelines.
• Contribute to continuous improvement of Clinical Operations processes, SOPs, templates, tools, and best practices; capture and implement lessons learned.
• Support departmental initiatives and other Clinical Operations 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 up to 15% of base salary, contingent upon meeting performance components

What This Job Offers

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