CRA Line Manager
医学在此前进。你也会这样做.Ergomed 是一个专业的临床研究组织，专注于罕见疾病和肿肿瘤学标志。我们关注最复杂的试验，经验，判断力和严格的运营责任最大的差异。我们与中小企业合作，通过早期发展来推移有希望的疗法，以便他们更快地接触到患者。我们故意选择复杂的工作。罕见病和肿肿瘤学的试验带来了真正的运行风险，我们的人员是减少它，同时保护时间表，数据质量以及网站和患者的体验的专家。这是一项要求高的，有意义的工作，在这里没有人忘记病人不能等待。这就是为什么文化对我们来说与能力一样重要。我们建立了一个协作的国际团队，人们可以分享想法，发展自己的职业生涯，并信任他们早就拥有资产。在北美，南美洲，欧洲，亚洲和澳大利亚的同事们一起，我们重视团队合作，灵活性以及工作-生活平衡的真正承诺，因为良好的科学来自于那些感觉得到支持的人。如果你想以目的，敏捷性产生影响力而努力，并且关心工作背后的人们，就像工作本身一样，我们很喜欢听从你。· 作为 CRA 的任何非项目特定需求的主要联系点。·管理业绩，支持 CRA 的培训需求和增长机会。·定期与 CRA 沟通以确保他们对分配的项目目标以及部门和企业战略和目标的了解，理解和遵守。· 在与资源团队合作开展新和正在进行的项目的资源解决方案；· 支持确定和运行公司策略和愿景，以便持续组织增长。·参与 CRA 招聘，面试和雇佣相关的活动。· 开展新的员工指导和集成。· 需要时与临床运营领导层其他成员参加项目相关会议。·确保持续评估 CRA 的绩效，包括监督和监测评价访问的执行。·协助制定部门质量标准和计划。·协助临床运作 SOP/WI 开发/审查过程。·建立和支持与 i 强大的专业关系。
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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.
- 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.
- 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
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.