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Senior Project Manager

Role overview

Qualifications

  • Experience serving as a Project Manager of international clinical trials in a CRO environment
  • Knowledge of Oncology and Rare Disease therapeutic areas
  • Experience in selecting and managing external service providers
  • Strong analytical, organizational and communication skills
  • Bachelor’s Degree in a science related discipline

Responsibilities

  • Ensure that projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
  • Liaise with project team members, provide training where needed and ensure correct allocation to tasks
  • Develop, review and edit project plans to assure consistency with goals and milestones
  • Organization and facilitation of project meetings related to study activities
  • Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
  • Represent Ergomed at external meetings, providing liaison with scientific/medical experts
  • Develop, review and edit relevant SOPs to assure consistency with Regulatory standards
  • Contribute to bid defense activities

Key facts

Other skills

  • Analytical Skills
  • Organizational Skills
  • Verbal Communication Skills
  • Teamwork
  • Physical Flexibility

About the company

PrimeVigilance logo

PrimeVigilance

Contract Research Organizations (CRO)

PrimeVigilance, an Ergomed company, was set up by former Pharmacovigilance Regulators in 2008. We have grown to become the leading Pharmacovigilance specialist company, delivering global solutions for both clinical safety and post-marketing pharmacovigilance, as well as medical information from our offices. Having successfully delivered Pharmacovigilance (PV) and Medical Information (MI) services for over 14 years, our experience enables us to offer a comprehensive, top quality, cost-effective, and innovative safety solution. Our flexible approach, tailor-made to work with clients, allows us to deliver the services that meet your clinical and post-marketing needs.From its operational hubs based in Europe, the USA, and Japan. PrimeVigilance manages a global Pharmacovigilance system with a choice of leading drug safety databases, stretching to more than 100 countries.• 900+ highly qualified professionals• Global leader in QPPV services• 24/7 multilingual call center• Choice of leading drug safety databases• Robotic Process Automation (RPA) expertise• Access to regulatory experts and key opinion leadersGLOBAL LIFE CYCLE MANAGEMENT SERVICES• PHARMACOVIGILANCE • PHARMACOEPIDEMIOLOGY & BENEFIT-RISK MANAGEMENT• AUDIT & INSPECTION• QUALITY MANAGEMENT• REGULATORY SCIENCE

Company details

IndustryContract Research Organizations (CRO)
Company size501 - 1000

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Job description

Company Description

Medicine moves forward here. So will you. 

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.  

We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. 

That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. 

If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you. 

Job Description

  • Ensure that projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards 

  • Liaise with project team members, provide training where needed and ensure correct allocation to tasks 

  • Develop, review and edit project plans to assure consistency with goals and milestones 

  • Organization and facilitation of project meetings related to study activities (study organization, initiation, execution, closure) 

  • Serve as primary point of contact with sponsor and Ergomed Senior Management on project status 

  • Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings, (e.g.EC/IRB) 

  • Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this. 

  • Contribute to bid defense activities 

Qualifications

 

  • Experience serving as a Project Manager of international clinical trials in a CRO environment 

  • Knowledge of Oncology and Rare Disease therapeutic areas  

  • Experience in selecting and managing external service providers 

  • Strong analytical, organizational and communication skills 

  • Bachelor’s Degree in a science related discipline. 

 

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.  

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. 

  • Quality: we hold ourselves to the standard patients deserve. 

  • Integrity and trust: we do the right thing, especially when it is hard. 

  • Drive and passion: we care about the outcome, because someone is waiting on it. 

  • Agility and responsiveness: we move quickly, because patients cannot wait. 

  • Belonging: everyone is welcome, and every voice counts. 

  • Collaborative partnerships: we go further by going together. 

We look forward to welcoming your application. 

 

 

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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