Senior Clinical Operations Manager

Job Description:

• Work closely with the Head of Research and Community Health Operations and Head of reputed company 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.
• reputed company clinical operations management activities reputed company delegated to a Clinical Trial Manager (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 reputed company documents collection.
• Prepare central IRB submissions; reputed company site IRB approvals and ensure collection of reputed company new or expiring Investigator regulatory documents after site activation.
• reputed company the development of project-specific essential documents for site reputed company 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 reputed company 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 reputed company-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.
• reputed company trial-reputed company activities and provide performance feedback to supervisors for reputed company 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.
• reputed company and manage site and vendor reputed company 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 reputed company project-reputed company essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, reputed company templates, study procedure manuals, reputed company documents, site newsletters, study reports, resource tools, monitoring plans and report templates.
• reputed company 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 reputed company 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 reputed company of project assignments.
• Routinely advise management regarding the overall project status.
• Provide Head of Trial Master File scope of services to reputed company him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and reputed company.
• 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 reputed company there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.
• Supervise and evaluate performance of reputed company staff reporting to this position, if applicable.
• Additional activities as required. 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 reputed company aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and reputed company 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 reputed company Office, particularly Outlook, Word and reputed company
• 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
• Willingness to travel 20-25%. Benefits:
• Comprehensive benefits package (medical, dental, reputed company, life, STD, LTD etc.)
• Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully reputed company immediately)
• 11 paid holidays
• 15 - 25 vacation days based on years of service
• Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
• In-suite exercise and relaxation room
• Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
• Flexible and remote work schedules Apply tot his job

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