Manager, Study Start Up and Regulatory Affairs

🔥 7 minutes ago

🇬🇧 United Kingdom – 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 and 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 • Assign departmental deliverables, monitor budgets and hours, and escalate out-of-scope work • Participate in business development meetings and contribute to proposals, regulatory sections, costings, and budgets • Provide strategic input into bids and support winning new business • Provide coaching, guidance, and performance feedback to team members • May line manage staff and perform other assigned duties

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • 6–8 years 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 • Knowledge of regulatory requirements and clinical study start-up processes • Experience with site selection through site initiation readiness • Ability to manage study start-up and regulatory activities for medium- to high-complexity projects • Ability to oversee essential document collection, review, compliance, and tracking • Ability to negotiate and execute clinical site agreements, ancillary agreements, and amendments • Ability to define and implement study start-up and regulatory strategies • Risk identification, assessment, and mitigation skills • Ability to monitor project budgets and identify out-of-scope work • Experience contributing to business development meetings, proposals, regulatory costing, and budgets

🏖️ Benefits

• Collaborative, international team environment • Career growth opportunities • Flexible work culture • Work-life balance • Coaching, guidance, and mentoring opportunities • Passionate and collaborative team of experts • Inclusive workplace where every voice counts

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