Manager Study Start Up and Regulatory Affairs in Kraków

Manager Study Start Up and Regulatory Affairs

Full-time Department: Study Start up and Regulatory Unit Medicine moves forward here. So willyou. Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,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, dataqualityand 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 theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported. If you wantworkwith 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 Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness. The manager actively assists senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff. Leads study start-up and regulatory activities for assigned projects of medium to high complexity, ensuring delivery aligned with timelines, quality standards, and regulatory requirements. Accountable for end-to-end delivery of study start-up and regulatory milestones across assigned projects. Ensure collection, review for completeness/compliance, and tracking of 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. Ensure negotiation and execution of clinical site agreements, ancillary agreements as well as amendments, in accordance with project requirements and country regulations and within the projected delivery timelines. Defines and implements study start-up and regulatory strategies at project level, ensuring alignment with sponsor expectations, regulatory requirements, and operational feasibility. Proactively identifies, assesses, and mitigates risks impacting study start-up and regulatory timelines, ensuring timely resolution of issues. Builds and maintains strong relationships with clients, regulatory authorities, and internal stakeholders to ensure effective collaboration and delivery. Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escape any OoS. Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets. Provides strategic input into bids and contributes to winning new business opportunities Provides coaching, guidance, and performance feedback to team members to support development and delivery excellence. Performs other work-related duties as assigned. Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience. 6-8 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role Proven ability to successfully manage global projects When you joinErgomedGroup, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin 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 theoutcome, becausesomeone is waitingonit. Agility and responsiveness:we movequickly, becausepatients 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.