Manager, Study Start Up and Regulatory Affairs

🔥 11 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Develop regulatory strategies based on regulatory requirements • Coordinate and oversee study start-up deliverables from site selection through site initiation readiness • Lead study start-up and regulatory activities for assigned medium- to high-complexity projects • Manage end-to-end study start-up and regulatory milestones • Collect, review, track, and resolve issues with essential study documents • Prepare study team reports and updates on document collection, review, and approval status • Negotiate and execute clinical site agreements, ancillary agreements, and amendments • Identify, assess, and mitigate risks affecting study start-up and regulatory timelines • Build and maintain relationships with clients, regulatory authorities, and internal stakeholders • Monitor departmental deliverables, project budgets, and hours against budget • Participate in business development meetings and develop or review regulatory proposal sections • Provide coaching, guidance, training, mentoring, and performance feedback to junior team members • Line manage staff when required • Perform other assigned work-related duties

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • 6–8 years of experience within the pharmaceutical or CRO industry or a regulatory body • At least 3 years in a leading/project management role • Proven ability to successfully manage global projects • Experience with regulatory requirements and study start-up activities • Ability to manage projects of medium to high complexity • Ability to develop regulatory strategies and oversee study start-up deliverables • Ability to manage clinical site agreements, ancillary agreements, and amendments • Ability to identify, assess, and mitigate study start-up and regulatory risks • Ability to monitor project budgets and escalate out-of-scope work • Ability to provide strategic input into bids, proposals, regulatory costing, and budgets

🏖️ Benefits

• Collaborative, international team environment • Flexible work-life balance • Career growth opportunities • Coaching, guidance, and mentoring opportunities • Opportunity to work on meaningful rare disease and oncology clinical research • Opportunity to contribute to new business proposals and business development • Diverse and inclusive workplace where every voice counts

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