研究专员（初创公司与法规事务）
Specialist Study Start Up & Regulatory Affairs
医学在这里不断前进，你也将如此。
Ergomed 是一家专注于罕见病和特定肿瘤适应症的临床研究组织。我们专注于最复杂的试验，这些研究中，经验、判断力和严谨的运营责任能带来最大的影响。我们与中小型生物科技公司合作，推动有前景的疗法进入早期开发阶段，使它们更快地到达患者手中。
我们有意选择复杂的工作。罕见病和肿瘤试验具有真正的运营风险，而我们的员工是降低这种风险的专家，在保护时间表、数据质量和站点及患者的体验的同时，做到这一点。这是一项要求高且有意义的工作，这里没有人会忘记患者不能等待。
因此，文化与能力一样重要。我们建立了一个协作、国际化的团队，人们分享想法、提升职业，并被信任在早期承担职责。我们的同事遍布北美、南美、欧洲、亚洲和澳大利亚，我们重视团队合作、灵活性和对工作与生活平衡的真实承诺，因为优秀的科学来自那些感到被支持的人。
如果你希望从事有目标的工作，拥有产生影响的敏捷性，并加入一个既关心工作本身也关心背后的人的团队，我们期待收到你的来信。
高级专员，研究启动与监管负责根据已建立的 SSU RA 管理计划完成研究启动和监管交付物。他们还作为 SSU/监管项目团队、监管机构、供应商和研究站点之间的联络人，在规划、组织和执行 SSU 和监管交付物时遵循项目、公司和行业监管策略。
· 在高级团队成员的指导下，独立管理低复杂度项目的启动活动，确保有效协调并交付分配的任务。
· 准备、收集、审查监管信息，以支持向国家监管机构和伦理委员会/IRB 提交初始授权和维护申请，符合相关法规要求。
· 收集、审查完整性和合规性，并跟踪研究启动所需的关键文件，以促进站点的高效启动和激活。调查不完整、不准确或缺失的文件，以确保信息的准确性和完整性。准备研究团队报告或更新，说明关键文件的状态。
查看英文原文
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.
The Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan. They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate and industry regulatory strategies.
· Under guidance of senior team members, independently manages study start-up activities for projects of low complexity, ensuring effective coordination and delivery of assigned.
· Prepare, collect, review regulatory information to support submissions to national authorities and ECs/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
· Collect, review for completeness and compliance, and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
· Responsible for drafting, negotiating, finalizing, and executing clinical site agreements, ancillary agreements as well as amendments at country or regional level, in accordance with project requirements and country regulations and within the projected delivery timelines.
· Responsible for site outreach in assigned country/countries; point of contact for site, sharing of non-confidential and confidential study information and management of confidential disclosure agreements
· Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to site activation readiness investigational product release, site activation and site initiation.
· Review all relevant documentation e.g. labels, patient information sheets, diary cards, insurance etc, to ensure compliance with ICH GCP & country specific requirements
· Arrange for and/or review translation of essential documents as required
· Contributes to the development of regulatory and study start-up strategies and supports preparation of SSU plans and related documentation
· Ensure timely and accurate completion of project trackers, filing in study portal and TMF, and QC of submission dossiers
· Ensures assigned deliverables are completed in accordance with project timelines and expectations.
· Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
- Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience
- Previous experience within the pharmaceutical/CRO industry
- Good knowledge of ICH GCP and national regulations for territories of competency
- Good written and verbal communication skills to clearly and concisely present information
- Proficiency in English, both written and verbal
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.