JOB SUMMARY:

The Clinical Project Manager is responsible for the ownership, accountability, and results of clinical trials. They provide project management and leadership to plan, prepare, and execute one (or more) clinical study(ies) from initiation to close out. The Clinical Project Manager interfaces internally with team members and across functional teams and acts as a liaison with external vendors contractors, consultants. The Clinical Project Manager is accountable for timeline development, communication, and study outcomes and milestones, and the delivery of trial(s) within quality parameters, timelines, scope, and budget. 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Implement, manage, and terminate clinical studies in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements.
• Develop detailed plans, prioritize tasks, coordinate, and provide oversight of all elements of the clinical trial(s) to attain project deliverables, and achieve project goals within specified timelines and budget.
• Communicate the status and progress of clinical trial(s), and raise issues related to study conduct including but not limited to: timelines, enrollment, and/or budget with study team members, functional teams, and management.
• Develop and implement appropriate actions to address issues with clinical trial(s). 
• Provide oversight of project team members and deliverables, and ensure all necessary project-specific training is provided
• Lead efforts to ensure on time development and appropriate distribution of study specific documents including study protocols, data management plans, statistical analysis plans, informed consent documents, case report forms, monitoring plans, study manuals, training plans and materials, and other study tools and plans.  
• Demonstrate thorough knowledge of and supervise others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
• Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.
• Supervise the set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF), EDC, etc. as applicable.
• Participate in the selection of, and management of issues related to study investigators, various clinical study contractors and vendors including contract research organization (CRO) staff, contract monitors (domestic and international), IRB/ECs, etc. 
• Review Monitoring Trip Reports provided by Monitors for all phases of clinical trial(s) including site evaluations, initiations, interim monitoring and close out visits.
• Provide mentoring to junior staff regarding protocols and site management.
• Responsible for baseline budget and timeline development and manage the study according to planned budget and timelines. 
• Oversee development and collection of site non disclosures, contracts and budgets. 
• Oversee site evaluations, activations, monitoring and closures to ensure on time delivery and act on any deviations from plan.   
• Select and qualify clinical trial investigational sites.
• Prepare, participate in and coordinate presentation of training materials to include study team member training, investigator meetings, Site Initiation materials and protocol training materials. protocols and other study requirements at study initiations at investigational sites when needed.
• Lead preparation and execution of study meetings (e.g., kick off meetings, investigator meetings, periodic study team meetings, etc.) and ensure documentation in the form of agendas and minutes.
• Develop and oversee the production and timely distribution of site binders.
• Manage the development and implementation of patient recruitment and patient retention strategies and oversee and track study enrollment.
• Oversee investigational product forecasting, distribution, accountability, and reconciliation.
• Ensure data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites.
• Participate in the development and review of Case Report Forms to ensure proper data is captured.
• Oversee the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
• Collaborate with regulatory affairs to ensure compliance with clinical trial registry requirements.
• Assist Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.
• Ensure clinical project audit and inspection readiness through the study lifecycle and contribute to CAPAs as required.
• Collaborate in the assessment of project risks and develop and implement study level risk management plans and reviews.   
• Oversee clinical trial(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
• Lead and coordinate the development of clinical study reports (interim, annual, and final) in collaboration with cross functional team members to support regulatory submissions. 

KNOWLEDGE, SKILLS AND ABILITIES:

• In depth understanding of ICH GCP Guidelines and other local or international guidance, regulation and codes of practice related to the execution of clinical trials, preferably ophthalmic devices.
• Organizational awareness to operate in cross-functional teams and provide leadership to other clinical staff members.
• Must recognize and commit to a sense of urgency, teamwork.
• Ability to take and maintain initiative.
• Possess strong interpersonal skills with the ability to manage and mentor others, interact with peers, medical professionals, consultants, and Regulatory Agencies as required.
• Effective time management skills with the ability to plan, prioritize, organize, and problem solve independently with the use of critical thinking skills.
• Outstanding oral and written communication skills to influence, inform or guide others.

EDUCATION AND EXPERIENCE:

• Bachelors or master’s degree within life sciences or related field.
• 5+ years clinical research experience including previous monitoring experience. 
• Prior experience (3+ years) in the planning, conduct and management of clinical trials, with strong preference given to ophthalmic device experience.
• Demonstrated ability to drive project related activities. 
• Previous experience leading, managing, and coaching direct reports
• Current ICH GCP certification. 

PHYSICAL REQUIREMENTS:

• Must be able to remain in a stationary position at least 50% of the time.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Ability to listen and speak with employees and external partners, stakeholders, etc. Must be able to exchange accurate information in these situations.
• Occasionally lift up to 25 pounds. This may be performed with reasonable accommodation.
• View and type on computer screens for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.

New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.