CRA Line Manager

Qualifications

• BA/BS in a Life Science field or commensurate experience

EXPERIENCE

• Demonstrated experience in clinical research. 
• Prior site monitoring experience including experience managing CRAs

SPECIAL SKILLS

• In-depth knowledge and experience of the drug development process including study initiation, clinical monitoring, drug safety, regulatory affairs, data management and analysis, and clinical study report generation. 
• Ability to travel approximately 20% both domestically and internationally. 

LANGUAGE SKILLS

• Fluent in English

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. 

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

• Serve as main point of contact for CRAs for any non-project specific needs.
• Manage performance and support training needs and growth opportunities of CRAs.
• Communicate regularly with CRAs to ensure their knowledge, understanding, and compliance with assigned project goals and departmental and corporate strategies and objectives.
• Plans and implements resource solutions for new and ongoing projects, working in collaboration with Resourcing team.
• Support to determine and operationalize corporate strategy and vision for continued organizational growth.
• Participate in activities related to CRA recruiting, interviewing and hiring.
• Conduct new employee orientation and onboarding.
• Participate in project related meetings with other members of Clinical Operations leadership, where needed.
• Ensure ongoing evaluation of CRA performance, including oversight of and performance of monitoring evaluation visits.
• Assist in the development of department quality standards and programs.
• Assist in Clinical Operations SOP/WI development/review processes.
• Establish & support strong professional relationships with internal and external stakeholders by building trust, open communication, and managing day-to day operational issues.
• Review and approve timesheets and discuss CRA utilization during regular calls.
• Perform regular monthly calls with all direct reports to assess workload balance, performance, upcoming deliverables, priorities, compliance to expected tasks.
• Review and approve non-billable expenses.
• Initiate and oversee Performance Improvement Plan with CRAs, as required.