Project Manager I

Job not on LinkedIn

🔥 1 minute ago

🌾 Iowa, Wisconsin – Remote

🌾 Iowa – Remote 🧀 Wisconsin – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

🚫👨‍🎓 No degree required

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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MERIT CRO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 $1.1M Venture Round - MERIT on 2023-07

Healthcare • Pharmaceuticals • SaaS

MERIT CRO is an innovative clinical endpoint expert and contract research organization that partners with CROs, pharmaceutical and biotech sponsors to provide centralized endpoint services for global clinical trials. It focuses on therapeutic areas including ophthalmology, oncology, respiratory and cardiology and offers specialized services such as reading center services, BCVA certification, centralized image storage, endpoint assessments, and clinical operations support. MERIT also provides a cloud-based software platform (EXCELSIOR) for real-time, single-system access to trial endpoints and emphasizes quality and compliance evidenced by ISO 13485 and ISO 27001 certifications and FDA 510(k) clearance. The company positions itself as a B2B service provider aimed at improving the reliability and efficiency of imaging- and endpoint-driven clinical trials.

📋 Description

• Accomplish the day-to-day operations of project management and administer activities regarding assigned studies • Support all study activities from study start-up through closeout and data lock • Assist with project management of clinical trial data in the EXCELSIOR™ cloud application environment • Perform data uploads and quality control functions • Organize, coordinate, develop, proofread, and maintain controlled project and regulatory documents • Respond to quality review audits and document responses • Assist with development and implementation of training programs • Prepare study start-up materials, organize internal start-up meetings, and follow up on action items • Maintain communication among the Project Management Division, sponsors, site staff, and other designated parties • Initiate and maintain Master Project Files and study files • Establish, create, distribute, and maintain study documents, reports, updates, status information, site lists, plans, correspondence, eligibility reports, and notifications • Attend internal and sponsor project meetings via teleconference or face-to-face • Independently process clinical data from start-up through database lock • Understand EXCELSIOR™, clinical trial protocols, and clinical trial conduct • Provide guidance and training to sponsors, CROs, and clinical sites on EXCELSIOR™ functionality and technical support • Configure studies within EXCELSIOR™ and assist with study-specific configuration review • Develop and perform project-specific user acceptance testing • Train internal teams and provide additional training support as required • Manage and review site surveys and update EXCELSIOR™ for site registration • Perform clinical site technician and equipment certification • Check in and quality-control images • Issue and review data query responses • Review, categorize, and respond to customer support and complaint tickets • Follow up with sites, sponsors, and reading center personnel regarding EXCELSIOR™ access and inactive users • Comply with company policies and Standard Operating Procedures (SOPs)

🎯 Requirements

• Minimum of a Bachelor’s degree in a health related, biological science, computer science, data entry, customer service or business management is preferred, or an equivalent combination of education, training, and work experience • A minimum of two (2) years of clinical trial or project management experience in a related field • Strong interpersonal and organizational skills • Excellent attention to detail • Ability to follow direction, assess Company needs and work independently • Proficiency in Microsoft Office software • Ability to learn Company specific software • Professional attitude and image appropriate for the work environment • Ability to participate and contribute in a team environment • Clear, concise, and effective oral and written communication • Must meet the stated physical requirements, including frequent lifting/moving up to 10 pounds and occasional lifting/moving up to 25 pounds • Licenses or Certifications Required: None