[Remote] Clinical Study Project Manager

Note: The job is a remote job and is open to candidates in USA. iuvo Clinical is a full-service ophthalmology-focused contract research organization dedicated to improving patients' quality of life with breakthrough eyecare therapies. The Clinical Study Project Manager is responsible for overseeing study teams and vendor activities during clinical studies, ensuring project timelines and budgets are met while maintaining effective communication with clients.

Responsibilities

• Act as primary contact with client. Develop and maintain rapport and good flow of communication with client. Align trial conduct with sponsor strategic objectives
• Responsible for overall project performance, including establishment of study timelines, management and execution of key deliverables, and proactive resourcing planning to identify members appropriate for project team and any resource needs/gaps
• Identify vendor requirements and manage vendor activities and inventories
• Identify and communicate risks. Recommend and lead the implementation of proactive mitigation strategies
• Oversee subject enrollment forecasting and evaluation of timeline impacts
• Drive issue resolution and continuous process improvement
• Responsible for meeting and communicating project timelines and budget internally and with client
• Oversee delivery of a clean and complete Trial Master File (TMF)
• Work directly with Study Manager, Data Manager, Group Project Manager, Group In House CRA Manager, and Group Field CRA Manager to co-manage in-house activities to execute project as contracted
• Review the project-related work products to check for accuracy and adherence to SOPs
• Oversee that appropriate study-related training is conducted for team members
• Prepare regular written and oral status reports for client. Participates in meetings at client’s facility and/or major conferences as requested by client
• Prepare and distribute internal and external meeting agendas and minutes as required
• For assigned projects, provide regular activity status, revenue and staffing forecast reports to iuvo executive staff for in-house operational planning and ongoing tracking
• Through ongoing monitoring of study budget, determine need for and generates change orders
• May provide input to clinical services SOPs and provide suggestions for optimizing and improving related operations
• May serve as a “trainer”/ “mentor” for less experienced clinical staff
• Work with business development personnel to participate in bid defense meetings and proposal presentations, as requested
• Utilize industry contacts and resources to provide suggestions for new markets and clients

Skills

• Strong proficiency with Microsoft Office (Word, Excel, Outlook, etc.)
• Adobe Acrobat, and survey tools such as web-based Survey platforms, Microsoft Forms
• Experience working with eTMF systems
• Proficiency with Microsoft Office (Word, Excel, Outlook, Teams) and other software/programs as applicable
• Effective verbal and written communication skills required to interact with clinicians, clients, vendors, FDA Inspectors and internal project team members through demonstration of excellent presentation and interpersonal skills, including clear, succinct, and timely communication
• Sharing ideas in a constructive and positive manner
• Listening to and objectively considering ideas and suggestions
• Keeping commitments
• Keeping others informed of work progress, timetables and issues
• Addressing problems/issues constructively to find mutually acceptable solutions
• Respecting the diversity of our work force in actions, words, and deeds
• Read and comprehend work instructions/SOPs and protocols and write clear concise reports
• Thorough understanding of Good Clinical Practice, ISO standards applicable to given studies, and FDA regulations regarding conduct of clinical studies, procurement of informed consent, and IRB responsibilities
• Strong working and speaking knowledge of applicable therapeutic area terminology
• Must be highly organized, able to efficiently schedule and execute follow-up of tasks, manage multiple priorities, demonstrate strong attention to detail and analytical skills
• Bachelor's degree preferred with 7 years of relevant experience

Benefits

• We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career!
• Office setting / remote home office.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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