Clinical Oversight Manager (COM) - USA

kps life; Palm Coast (FL); Remote; USD 120,000 - 170,000; Full time

Job summary

KPS Life is seeking a Clinical Oversight Manager to work with one of our Sponsor partners. This role can be remotely based anywhere in the Northeast USA, within one hour of a major airport.

The position requires extensive experience in clinical research, site monitoring, and regulatory compliance, with hands-on involvement in audits, CRO oversight, and study governance. Strong leadership and communication skills are essential for success in a matrix environment.

Qualifications

• Minimum 8+ years’ clinical research experience.
• 6+ years’ experience in monitoring and site management of industry-sponsored clinical research.
• Thorough understanding of drug development and clinical trial process.
• Ability to assess CRO monitoring performance and provide remediation.
• Participation in audits and site inspections.
• Active management experience of countries and sites in a region.
• Thorough knowledge of ICH guidelines/GCP and applicability to clinical development.

Responsibilities

• Contribute to development of the Overall Study Management Plan and site-level plans.
• Define standards and quality indicators for site management and monitoring.
• Ensure high-quality conduct and execution of clinical studies per protocol and regulations.
• Address issues identified in study conduct and monitoring with Sponsor management.
• May conduct oversight monitoring visits and review monitoring visit reports.
• Review submission documents for IRBs/IECs and Health Authorities as appropriate.
• Assist with translations or verification of translations.
• Implement approved communication plans with external partners or CROs.
• Support collection of study performance information (start-up, enrollment, data timeliness/quality).
• Review monitoring visit reports for finalization and consistency.

Skills

Project management

ICH/GCP knowledge

Matrix environment

Interpersonal skills

Problem solving

Regulatory coordination

Decision making

Communication skills

Education

BSc/MSc in life science

Health/medical degree

RN diploma / Medical technologist

Job description

KPS Life is seeking a Clinical Oversight Manager to work with one of our Sponsor partners. This role can be remotely based anywhere in the Northeast USA, within one hour of a major airport.

The (C)OM):

• contributes to development of the Overall Study Management Plan, the study level Site and Monitoring Plan and the Oversight Monitoring Plan.
• contributes to the definition of appropriate standards and quality indicators for site management and monitoring.
• ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards.
• addresses issues identified with study conduct, monitoring and site management with Sponsor’s management, are appropriately communicated/escalated and follows up through resolution.
• May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed.
• reviews the submission documents for IRBs/IECs and Health Authorities as appropriate for assigned sites/countries/region.
• may assist with translations or verification of translations.
• implements approved communication plans with external strategic partners or CROs.
• supports the collection of key study performance information, including study start-up metrics, enrollment, data collection timeliness/quality.
• reviews monitoring visit reports for finalization/consistency/issues according to study monitoring plan.
• utilizes available tools/systems to assess vendor and site performance.
• ensures inspection readiness at the study sites and follow up corrective/preventive actions.
• maintains good communication and working relationships with investigators, internal stake-holders and external services providers (CROs).
• provide input into study feasibility for assigned sites/countries/region and supports the on-time delivery of a clinical study data, globally (if applicable)

The (C)OM) Will Have:

• computer literacy in appropriate software(s).
• the ability to work well within a matrix environment with excellent interpersonal (written and verbal) and decision-making skills.
• demonstrated innovation skills, drive, energy and enthusiasm to deliver the study program objectives.
• demonstrated management of all clinical study aspects (developing a protocol to clinical study report).
• the ability to identify, solve and elevate issues that arise at study sites and within site management
• comprehensive/extensive knowledge of ICH guidelines/GCP and remains current on medical/scientific aspects.
• demonstrated project management skills i.e. (simultaneous management of multiple vendors, sites and studies. Possesses excellent planning, time management and coordination skills.
• demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.

The (C)OM) Will Have:

• a degree (BSc/MSc or equivalent preferred) in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area.
• other degrees and certificates considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• a minimum of 8+ years’ relevant clinical research (or related) experience.
• 6+ years’ experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent).
• a thorough understanding of the drug development and clinical trial process.
• the ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary.
• the ability to participate in preparation, conduct and follow up of audits and site inspections.
• active management experience of countries and sites in a region.
• thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.