Senior Clinical Study Manager - Remote

Penfield Search Partners Ltd.; Fairfield (CT); Remote; USD 140,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking aSr. Clinical Study Manager to lead end-to-end clinical operations for pre-clinical and diagnostic trials.

You will oversee planning, budgeting, resource allocation, and CRO coordination while guiding staff across cross-functional teams to meet timelines and quality standards. The role requires 8+ years in clinical research within medical devices, IVD, biotech, or pharma and strong regulatory knowledge.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.
• 8+ years of clinical research within medical devices, IVD, biotech, or pharma.

Responsibilities

• Oversee full scope of clinical studies from planning through completion.
• Lead Clinical Operations staff and manage CRO activities as needed.
• Develop study budgets and timelines with risk mitigation plans.
• Ensure regulatory compliance and high-quality study documentation.
• Provide regular leadership updates on milestones, budget, and performance.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Clinical research experience

Technical writing

Education

BSc or equivalent (scientific field)

Job description

Contact: Alexandra Spink - [e-mail] 3rd party candidatesThe Sr. Clinical Study Manager role is responsible for managing the overall clinical operations of pre-clinical and clinical diagnostic trials, including study planning, budgeting, resource management, and, when applicable, oversight of contract research organizations (CROs).The Sr. Clinical Study Manager will provide operational leadership and mentorship to Clinical Operations staff and will collaborate closely with cross-functional teams to ensure clinical studies are executed according to established timelines, budgets, quality standards, and regulatory requirements.This is a remote position with travel to company headquarters and/or clinical sites on a minimal and as-needed basis.Key ResponsibilitiesManage the full scope of clinical studies from planning through completion.Oversee Clinical Operations staff, including regular and contract personnel, and manage all aspects of the clinical operational plan.Develop study-related documents and provide overall direction to clinical sites, including support for protocol development and implementation.Create, manage, and monitor clinical study budgets.Develop contingency plans and risk-mitigation strategies for clinical studies.Manage study timelines, milestones, resources, and deliverables to ensure successful execution.Oversee and manage CRO activities, when applicable.Develop and maintain effective communication across functions, including Executive/Leadership, Research & Development, Medical Affairs, Scientific Affairs, Regulatory Affairs, Finance, and Commercial teams.Provide regular reporting on study timelines, milestones, budget, and operational performance, with recommendations for adjustments as needed.Support compliance with applicable regulatory requirements, company procedures, and clinical research standards.Provide guidance, oversight, and mentorship to Clinical Operations team members.Essential QualificationsBachelor's degree in a scientific discipline or equivalent combination of education and experience.8+ years of clinical research experience within the medical device, in vitro diagnostics (IVD), biotechnology, or pharmaceutical industry.Working knowledge of applicable FDA regulatory requirements related to clinical research.Strong oral and written communication skills.Strong technical writing and documentation skills.Ability to effectively collaborate with cross-functional teams and external partners.Ability and willingness to travel up to 20% under normal operating conditions.Preferred QualificationsAt least 3 years of Clinical Research Associate (CRA) experience and 3 years of clinical study management experience.Experience managing in vitro diagnostic clinical trials.Experience with infectious disease and/or oncology clinical trials.Experience managing clinical studies through CROs and external clinical partners.Experience developing and implementing clinical operational plans, budgets, timelines, and risk-mitigation strategies.