Clinical Team Manager

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 16%

What it means: the chance that no one is really hiring for this job.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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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Manage assigned clinical teams, including CRAs • Develop, review, and revise clinical trial documents, including Clinical Monitoring Plans • Support project managers with study KPIs, timelines, budgets, invoicing, and staff time approval • Contribute to clinical risk management and Critical to Quality Factors and Quality Tolerance Limits • Recommend investigators and sites and review and approve PSV reports • Oversee site initiations, supply management, site activation documentation, CRA assignments, and site visit schedules • Organize internal project team meetings and provide study status and protocol deviation updates • Support setup and maintenance of trial master files and oversee ongoing and final quality control • Review CRA site visit reports and ensure timely, high-quality completion • Manage investigational product and study supplies • Review data listings and query reports, identify trends, and implement mitigation or retraining actions • Oversee protocol deviation and study non-compliance documentation, tracking, escalation, and corrective/preventive actions • Act as site contact when CRAs are unavailable and escalate unresolved issues to project management • Oversee clinical staff tasks, including CRA travel approvals • Manage trial close-out activities • Communicate and collaborate with sponsors, investigators, partners, and cross-functional teams • Support patient recruitment and retention plans • Coordinate preparation for site audits and inspections and oversee corrective and preventive action plans • Mentor and train new staff and conduct Monitoring Evaluation Visits • Oversee contracting or invoicing of local clinical vendors • Develop and revise SOPs in accordance with Good Clinical Practices and regulatory requirements • Participate in bid defense meetings and company process improvement initiatives • Perform monitoring activities as needed based on project needs

🎯 Requirements

• Degree or RN degree in a life science or other related field, or equivalent education and experience • Minimum of 6 years of clinical research experience in multiple studies and countries • Experience managing the clinical part of studies in more than one region or equivalent study complexities • Ability to mentor and train other CTMs and CRAs in a positive and effective manner • In-depth knowledge of clinical trials and the critical elements for success in clinical trials • Diverse therapeutic area expertise and skills

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work environment • Work-life balance • Passionate and collaborative team of experts • Opportunity to help bring safe and effective pharmaceutical treatments to patients worldwide

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