Senior Clinical Project Manager

Job not on LinkedIn

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $150k - $175k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 6%

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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Uniphar

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1987

💊 Pharmaceuticals

🏭 Manufacturing

🏥 Healthcare

Pharmaceuticals • Manufacturing • Healthcare

Uniphar is a pharmaceutical company. Its tagline "Valorizando vidas" (valuing lives) and LinkedIn description "Empresa farmacêutica" indicate a focus on pharmaceutical manufacturing and activities related to producing and distributing medicines.

📋 Description

• Manage the overall execution of clinical operations activities for Phase I through Phase III trials • Serve as primary contact for CROs, Service Providers, site investigators, study personnel, internal Uniphar functional areas, Product Development Team members, and partners • Manage clinical trials from pre-study planning and protocol review through clinical study report finalization for regulatory submission • Ensure trial conduct follows ICH-GCP, FDA/EMA and other regulatory authority requirements, SOPs, timelines, budgets, operational procedures, and quality standards • Manage study activities, timelines, goals, budgets, and GCP/ICH compliance • Oversee CRO and vendor activities, contracts, budgets, and invoices • Lead internal study team meetings and coordinate study-related documents and operational manuals • Oversee investigator recruitment and trial conduct at investigative sites • Participate in monitoring visits, review monitoring reports and letters, and ensure CRO quality • Plan and lead Investigators' Meetings, Site Initiation Visits, CRA/Monitor training, and other study-related training • Track data collection, query resolution, monitoring, protocol adherence, and protocol deviations • Escalate project issues and risks to Senior Management and implement solutions • Conduct clinical data quality control and develop corrective action plans • Provide regular study updates and status reports to Senior Management • Support knowledge management, SOP preparation, data monitoring committees, CRO audits, and vendor qualification activities • Collaborate with Project Management & Planning to forecast budgets and provide input to integrated study timelines • Perform assigned sub-projects and other duties as directed by Senior Management

🎯 Requirements

• BS/BA degree or equivalent (background in life sciences preferred) • Eight or more years of clinical trial research management experience in a pharmaceutical, biotechnology, or CRO setting • At least 2 years of project management experience • At least 4 years of monitoring experience, with ability to independently perform all types of monitoring visits • Demonstrated experience managing multiple or complex projects across Phase I through Phase III • Experience with global clinical trials and multiple-CRO partners preferred • Experience managing CROs, Service Providers, and contractors • Previous experience managing vendor contracts and budgets preferred • Strong understanding of clinical research operations • Knowledge of FDA regulations, ICH/GCP guidelines, and their interpretation and implementation • Ability to work effectively with study teams, cross-functional team members, and external partners/Service Providers • Strong operational and management skills with attention to detail • Excellent communication skills • Proficiency with Microsoft Outlook, Excel, Word, PowerPoint, and Project • Willingness to travel up to 20%, depending on assigned responsibilities

🏖️ Benefits

• Bonus • Equal opportunity employment • Willingness to travel up to 20% depending on assigned responsibilities