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Clinical Study Project Manager

IUVO BIOSCIENCE OPERATIONS, LLC
Remote

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Job Details

$110,000 - $140,000 a year

Qualifications

Computer operation
Microsoft Excel
Web-based survey tools
Microsoft Outlook
Informed consent
Research ethical considerations
ISO standards
Digital survey tools
Microsoft Teams
Clinical quality assurance standards
Video conferences (communication methods)
IRB compliance
Medical terminology
Adobe Acrobat
FDA regulations

Full Job Description

A Trusted CRO Partner for the Future of Eye Care

iuvo Clinical is a full-service ophthalmology-focused contract research organization(CRO) dedicated to improving patient’s quality of life with breakthrough eyecare therapies. We combine decades of specialized experience with a high touch,high science approach, partnering with innovators to accelerate ophthalmicbreakthroughs from concept to commercialization. Whether advancing a novelretinal therapy or supporting a complex ocular device trial, we provide theexpertise, flexibility, and personal dedication to ensure clinical trialsuccess.

We offer a comprehensive benefits package and the opportunity to broaden your experience and grow your career!

We currently have an opportunity for a Clinical Study Project Manager to join our team!

SUMMARY

The Project Manager is responsible for study team and vendor oversight during the course of a clinical study, from start-up through close-out. The Project Manager works with clinicians, allied healthcare personnel, clients, vendors, FDA inspectors, and iuvo staff by:

ESSENTIAL DUTIES AND 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.

QUALIFICATION REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree preferred with 7 years of relevant experience.

COMPUTER 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.

COMMUNICATION SKILLS

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

OTHER SKILLS and ABILITIES

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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit or stand at a desk, talk and hear.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Office setting / remote home office. iuvo Clinical fosters a video-first environment; employees are expected to have their cameras on for all internal and external meetings, check-ins, and collaborative sessions.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

LOCATION Remote

TRAVEL <5% travel

DISCLAIMER

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

iuvo Clinical is an Equal Opportunity Employer

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Study Manager jobs

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