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This range is provided by Alimentiv. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Responsibilities

Strategic Leadership

• Develop and implement global and regional strategies for efficient study start-up operations
• Define key performance indicators (KPIs) to monitor progress, quality, and timelines
• Lead and support geographic expansion of Study Start-up team; lead process improvement initiatives to streamline start-up activities
• Estimate future resource requirements, create and support hiring plan

Operational Management

• Support country selection, manage feasibility and site identification activities
• Ensure site activation timelines are achieved according to study plans; proactively identify mitigation plans and review with project management if plans are at risk
• Supervise contract and budget negotiation processes
• Monitor portfolio performance against site activation timelines and metrics (e.g., as defined by corporate objectives), while adhering to budget targets

Business Development & Commercial Support

• Support country strategy for proposals, and creation of presentation materials for start-up strategy

Team Management & Engagement

• Lead and mentor SSU team leads and specialists across regions
• Build a high-performing team through training, coaching, and performance management
• Foster collaboration between study start-up, regulatory, legal, project management, Site Engagement team and clinical operations
• Efficiently manage allocations of study start-up staff which includes feasibility and document collection and frequently update resource algorithms based on portfolio needs
• Provide strong leadership and management to the study start-up team, addressing escalated / recurrent issues, finding resolutions and mitigations, and continuously improving operational efficiencies of study start up activities

Quality & Compliance

• Ensure all start-up activities adhere to ICH-GCP, regulatory guidelines, and internal SOPs
• Support audits and inspections related to study initiation

Qualifications

• Minimum 10 years related clinical operations experience, requirement for minimum 5 years of experience in overseeing start-up function & leadership
• BSc required in Life Sciences (advanced degrees preferred)
• Demonstrated experience in managing process improvement initiatives in Study Start-up
• Proven experience managing global start-up teams and CRO partnerships
• In-depth knowledge of global regulatory requirements and ethics submission processes
• Excellent leadership, communication, and organizational skills
• Strong problem-solving and decision-making abilities
• Proficiency in spoken and written English required

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

+ Bonus Please note the above range is applicable for candidates residing in Germany - our Talent Acquisition team will discuss country-specific compensation and benefits for those candidates residing in Hungary or Poland at the time of initial contact.

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Seniority level

Not Applicable

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Pharmaceutical Manufacturing