Senior Clinical Trial Manager (Contract)

GENERAL SUMMARY: 

4DMT is seeking an experienced and motivated Senior Clinical Trial Manager (Contract) to support the Company’s clinical trial activities. This position reports to the Associate Director, Clinical Operations within the retina program and is responsible for overseeing and managing the day-to-day operations of a Phase 3 multi site clinical study, including trial start-up, conduct, and close-out activities.  Some ophthalmology experience strongly desired.  In addition, experience with vendor management and CRO oversight required. 

MAJOR DUTIES & RESPONSIBILITIES: 

• Manage protocol execution, including oversight of the CRO, other study service providers, and consultants involved in a clinical trial 

• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership 

• Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs 

• Assist in the preparation and review of clinical trial documentation, such as protocols, informed consent forms, pharmacy and laboratory manuals, clinical monitoring plans, project plans, case report forms, vendor management plans, clinical study reports, and other study-level documents 

• Develop internal tracking and reporting tools to report study status to leadership and facilitate internal project team meetings 

• Support the management of the Trial Master File (TMF) to ensure compliance/inspection readiness 

• Participate in and coordinate the resolution of audit findings and ensure that clinical trial documentation, including central clinical files, remains audit-ready 

• Identify, mitigate, and manage risks, including timely issue review, escalation, and management to support trend analysis and risk prevention 

• Support the selection and study-specific training of CRO study staff, monitors, investigational sites, and service providers under the AD/Director of Clinical Operations 

• Facilitate study start-up with CROs and clinical sites as necessary, including working closely with the CRO to complete template clinical documents, such as source document worksheets, CRF specifications and development, clinical site agreements, and other study documentation 

• Assist data management personnel with activities associated with database lock and clinical study data analyses, and provide study-specific input to the preparation of clinical study reports as directed 

• Ensure timely response to queries and monitoring discrepancies 

• Aid in the planning and execution of investigator meetings  

• Present during cross-functional study execution team (SET) meetings in support of study deliverables 

• May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff and/or compliance personnel, including pre-study qualification visits, site initiation visits, eligibility review visits, routine study visits, trial master file review visits, and vendor qualification or selection visits 

• Oversee outsourced monitoring by reviewing monitoring reports to ensure quality and resolution of site-related issues 

• Ensure tracking and review of protocol deviations and assess their impact on study data 

• Provide oversight of clinical supply forecasting, including study drug and other supplies 

• May manage and/or oversee the work of junior Clinical Operations staff 

• May support development and review of Clinical SOPs and other department initiatives 

• Travel as needed to sites, conferences, and industry meetings 

QUALIFICATIONS: 

Education: 

• B.A./B.S. degree 

 Experience: 

• 7+ years of clinical research experience within the biotech industry or a similar combination of experience (biotech, pharma, CRO, etc.)
• Some ophthalmology strongly desired
• Experience developing trial plans, including creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management 

 Other Qualifications/Skills: 

(non-technical and technical skills) 

• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management; strong clinical study management skills 

• Understanding of, and experience with, the regulatory framework applicable to interactions with HCPs, payers, advocacy groups, and other business partners 

• Proven leadership skills to direct protocol execution and ensure timeline, budget, and quality metrics are met 

• Excellent communication skills to effectively disseminate information to the project team and outside parties 

• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology 

• Excellent organizational, conflict resolution, prioritization, and negotiation skills 

• Proven ability in creative problem-solving and exercising sound judgment 

• Team-oriented, with the ability to collaborate effectively with the study team, cross-functional team members, and external partners 

• Ability to handle a high volume of highly complex tasks within a given timeline 

• Ability to develop therapeutic area knowledge and expertise through internal training and external conference attendance 

• Proficient computer skills, specifically with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook 

• Working knowledge of MS Project for developing and updating clinical study timelines 

Travel: 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). 

Hourly compensation range: $84.00 - 95.00 

Please note that the hourly compensation range and actual hourly rate offered to the final candidate depend on various factors, including the candidate’s geographical location, relevant work experience, skills, and years of experience.