Director, Study Start Up – EU

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Oversee the Study Start Up (SSU) team, including SSUAs and SSUA Managers, in designated regions.

• Formulate and implement business strategies that align with project delivery objectives.

• Manage staff performance and development with a focus on achieving operational excellence.

• Engage directly with clients to foster ongoing business relationships.

• Collaborate with Project Management, Clinical Leadership, and Business Development to oversee contracts and client expectations.

• Direct SSU activities such as essential document collection, EC/IRB submissions, site initiation, Ethical Committee submissions, and maintain close collaboration with site teams.

• Propel process enhancements and create training materials.

• Lead teams to achieve departmental metrics that support business initiatives.

• Address and escalate complex risks and issues through root-cause analysis.

• Supervise SSU performance and teams within the assigned regions.

• Manage staffing, resources, and departmental utilization efficiently.

• Drive teams to adhere to project timelines.

• Collaborate with the VP to enhance and streamline global SSU processes.

• Work in partnership with SSU management in the US and other regions.

• Ensure that SSU processes are proactive and executed in accordance with contractual obligations.

• Implement risk-management strategies and identify opportunities for productivity and cost reduction.

• Contribute to business development efforts and proposal specifications.

• Participate in metric reporting and management meetings.

• Determine resourcing and staffing needs for new studies.

• Mentor and manage direct reports, focusing on training, performance management, and career growth.

• Manage multiple priorities in a fast-paced environment.

• Ensure effective transition planning and communication with stakeholders regarding staff changes.

• Review and provide guidance on SSU-related SOPs, WGs, and ADs.

• Share expertise with other managers.

• Create clear internal and external documentation and presentations.

⛳️ Requirements

• A Bachelor’s degree or its equivalent from an accredited institution in a clinical, scientific, or health-related field.

• 7-9 years of relevant experience in health sciences.

• Preferred experience in clinical trials support or the pharmaceutical industry.

• Strong preference for direct experience in study start-up roles.

• 5-7 years of experience in personnel management and oversight of larger teams preferred.

• Proficiency in ICH/GCP and/or ISO14155 standards.

• In-depth understanding of country-specific regulatory requirements for drug/device research and development in clinical trials.

• Familiarity with FDA, European Regulatory, and EC procedures as applicable.

• Knowledge of site and institution-specific contract requirements.

🏝️ Benefits

• Flexibility and balance to support your personal life.

• Opportunities for growth, skill enhancement, and career development.