Sr. Manager, Clinical Oversight Monitoring

GENERAL SUMMARY: 

The Sr. Manager, Clinical Oversight Monitoring (COM Sr. Mgr.) supports the Associate Director, Monitoring Oversight Management, in executing the clinical oversight program across 4DMT studies. This role is responsible for ensuring that clinical monitoring activities performed by CROs and contract monitors align with Clinical Monitoring Plans, study protocols, and ICH/GCP requirements. The Sr. Mgr. will drive consistency in monitoring oversight practices, manage day-to-day execution of oversight tools and processes, and contribute to maintaining inspection readiness and monitoring quality across global programs.

MAJOR DUTIES & RESPONSIBILITIES:  

• Execute oversight activities in alignment with the Clinical Oversight Monitoring Plan and related SOPs.
• Partner with the Associate Director to refine and implement oversight tools, trackers, and metrics dashboards.
• Conduct quality control (QC) review of monitoring visit reports and follow-up letters to assess completeness, accuracy, and compliance with monitoring expectations.
• Track visit scheduling, report completion metrics, protocol deviations, and issue resolution to identify trends and risks across CRO, monitor, and site levels.
• Support the development and maintenance of monitoring oversight dashboards and performance metrics (e.g., timeliness, completeness, issue closure, out-of-window visits).
• Assist in implementation of risk-based oversight elements such as key risk indicators (KRIs), key performance indicators (KPIs), and quality tolerance limits (QTLs).
• Collaborate cross-functionally with Clinical Operations, Quality Assurance, and Data Management to ensure consistency in monitoring-related communications, escalation pathways, and issue management.
• Support vendor oversight by reviewing CRO performance reports, contributing to issue escalation, and tracking CAPA progress.
• Participate in inspection readiness activities, document reviews, and process audits to ensure oversight documentation is accurate and current.
• Assist in process improvement initiatives by analyzing oversight data and identifying areas for refinement or standardization.
• Maintain oversight documentation, trackers, and archives to ensure audit and inspection preparedness.
• Support onboarding and training of new COM team members and vendor associates on oversight tools and processes.
• Travel as required (estimated up to 20%).
• Other duties as assigned. Management reserves the right to adjust responsibilities as business needs evolve.

QUALIFICATIONS: 

Education: 

• A./B.S. degree in related Life Sciences discipline required
• Equivalent combination of education and applicable job experience may be considered.

Experience: 

• A./B.S. with 7+ years of experience in clinical monitoring or oversight roles.
• Hands-on experience in clinical monitoring, including review of monitoring visit reports and vendor deliverables.
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Experience supporting risk-based monitoring (RBM) and quality metrics programs.
• Demonstrated ability to review, interpret, and analyze monitoring data and reports.
• Familiarity with vendor oversight processes, including KPI tracking and issue management.
• Experience supporting audit or inspection readiness activities.
• Proficiency with oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office Suite).
• Experience in ophthalmology or retina therapeutic areas preferred.

Other Qualifications/Skills:

• The ideal candidate will embody 4DMTs core values: Dare to Cure - Break Boundaries - Beyond Yourself - Prepare & Executive Relentlessly
• Strong interpersonal communication (written and verbal), and organizational skills
• Able to motivate a team to work effectively in a fast-paced and changing environment
• Strong work ethic and demonstrated ability to deliver assignments on time
• Proficient with office automation tools, such as Microsoft Office toolkit. Excellent Microsoft Excel skills specifically.
• Strong professional experience in a similar role within the pharmaceutical industry.
• Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Travel: Up to 20%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $134,000/yr - $178,000/yr

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.