Manager Study Start Up and Regulatory Affairs

ERGOMED; Kraków; On-site; PLN 180,000 - 280,000; Full time

Job summary

Ergomed is a specialist clinical research organization focusing on rare disease and oncology trials, offering complex, high-quality regulatory services. The Manager, Study Start Up and Regulatory Affairs leads SSU and regulatory activities, provides strategic guidance, and mentors junior staff across global projects.

The role involves coordinating site selection through activation, ensuring regulatory compliance, and contributing to bids and proposals to win new business.

Qualifications

• 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.
• At least 3 years in a leading/project management role, proven ability to manage global projects.

Responsibilities

• Lead study start-up and regulatory activities for medium to high complexity projects.
• Provide strategic regulatory guidance, training, coaching and mentoring to junior staff.
• Negotiate and execute clinical site agreements and amendments within timelines.
• Identify and mitigate regulatory risks to timelines and deliverables.

Skills

Regulatory affairs

Project management

Cross-functional leadership

Education

Graduate degree in Chemistry or Life Sciences

Nursing (or equivalent)

Job description

Company Description

Medicine moves forward here. So will you.

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

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.

Qualifications

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.

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.