Director, Study Start Up – EU

Premier Research

. Lead the Study Start Up group, including SSUAs and SSUA Managers, within assigned regions .

Posted 9/30/2026full-timeRemote • Poland, SpainLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading Study Start Up teams, managing clinical trial processes, and ensuring compliance with regulatory requirements. Proven ability to develop business strategies, mentor staff, and drive operational excellence in a fast-paced environment.

Highest-signal resume keywords

Study Start Up LeadershipClinical Trials SupportPersonnel ManagementICH/GCP ExpertiseRegulatory Compliance Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study Start Up ManagementClinical Trial ProcessesRisk ManagementDocument CollectionEC/IRB SubmissionsPerformance ManagementRoot-Cause AnalysisMetric ReportingContract ManagementTraining Development

Soft Skills

Team LeadershipClient InteractionCollaborationCommunicationProblem Solving

Industry Keywords

Health SciencesPharmaceutical IndustryFDA RegulationsEuropean Regulatory ProceduresISO14155 RequirementsCountry-Specific Regulatory RequirementsSOP ReviewStakeholder CommunicationBusiness DevelopmentOperational Excellence

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the Study Start Up group, including SSUAs and SSUA Managers, within assigned regions
Develop and execute business strategy aligned to project delivery
Performance-manage and develop staff while striving for operational excellence
Interact directly with clients to support repeat business
Collaborate with Project Management, Clinical Leadership, and Business Development to manage contracts and client expectations
Lead SSU activities including essential document collection, EC/IRB submissions, site initiation, Ethical Committee submissions, and close collaboration with site teams
Drive process improvements and develop training materials
Manage teams to deliver departmental metrics supporting business initiatives
Resolve and escalate complex risks and issues using root-cause analysis
Oversee SSU performance and teams within assigned regions
Manage staffing, resources, and departmental utilization
Drive teams to meet project timelines
Partner with the VP to improve and streamline global SSU processes
Collaborate with SSU management in the US and other regions
Ensure SSU processes are proactive and completed according to contractual agreements
Apply risk-management principles and identify productivity and cost-reduction opportunities
Contribute to business development and proposal specifications
Participate in metric reporting and management meetings
Identify resourcing and staffing for new studies
Manage and mentor direct reports, including training, performance management, and career development
Prioritize multiple assignments in a fast-paced environment
Ensure transition planning and stakeholder communication for staff changes
Review and advise on SSU-related SOPs, WGs, and ADs
Share knowledge with other managers
Produce concise internal and external documentation and presentations

Requirements

What you’ll need

Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, scientific or health related field
7-9 years of related experience in health sciences
Clinical trials support or pharmaceutical industry experience preferred
Direct experience in study start up roles highly preferred
5-7 years of personnel management and oversight of larger groups preferred
Expertise in ICH/GCP and/or ISO14155 requirements
Detailed knowledge of relevant country-specific regulatory drug/device research and development requirements for conducting clinical trials
Working knowledge of FDA, European Regulatory and EC procedures as applicable
Knowledge of site and institution-specific contract requirements

Benefits

Comp & perks

Flexibility and balance to support your life
Growth, skills, and career development opportunities