Senior Clinical Trial Project Manager

CPC is an academic research organization seeking a Senior Clinical Trial Project Manager to serve as the primary contact for industry-sponsored clinical trials and assigned projects. The role oversees trial operations, project teams, timelines, vendors, regulatory and site activities, and endpoint and specialty services while ensuring quality and sponsor communication.

Responsibilities:

• Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency
• Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables
• Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). For single-site or smaller multi-center studies in which these activities are not delegated to a CTM:
• Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract
• Identify the required regulatory documents for investigational product (IP) release and oversee documents collection
• Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation
• Oversee the development of project-specific essential documents for site oversight and development of site materials
• Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs)
• Work with CRAs on overall site management including identification, and resolution of site related compliance issues
• Prepare study enrollment reports and review site issues with the project team
• Manage and approve site payments as applicable
• Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables
• Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations
• Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation
• Oversee trial-related activities and provide performance feedback to supervisors for all project team members
• Participate in the review, development and testing of study databases
• Provide investigational product or device tracking and disposition as required by project
• Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services
• Identify vendors and manage vendor services
• Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates
• Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings
• Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks
• Ensure the overall quality of project services and deliverables
• Provide necessary updates and reports to the sponsor as outlined by the contract
• Plan and oversee the execution of investigator meetings as contracted
• Work with the business development team on budgets, proposals and change orders
• Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements
• Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. Routinely advise management regarding the overall project status
• Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper
• Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented
• Supervise and evaluate performance of all staff reporting to this position, if applicable
• Additional activities as required
• Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services
• Provide timely feedback to the Head of Research and Community Health Operations, and the Head of Endpoint and Specialty Services on the progress of project assignments. Routinely advise management regarding the overall project status
• Manage contracted deliverables for external committees (e.g., data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials
• Oversee SAE process and assure execution of safety plans
• Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites
• Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project
• Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required
• Manage acquisition and supply of Endpoint and Specialty Services-specific materials to study sites
• Provide feedback to study sites on tracing and quality issues, as required by project
• Manage and conduct Endpoint and Specialty Services CPC Core Lab activities as deemed necessary

Requirements:

• A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience)
• 5 years of experience in a clinical research setting (required)
• 3 years of sponsor or CRO clinical research project/clinical operations management experience
• Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other COMs
• Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials
• Proficiency in Microsoft Office, particularly Outlook, Word and Excel
• Excellent communication and organizational skills
• Great attention to detail
• Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting
• Ability to organize, instruct and supervise staff, while promoting group effort and achievement
• Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively