IQVIA

Global Study Associate Director – Sponsor Dedicated

IQVIA

full-time

Posted on:

Location Type: Office

Location: Barcelona • 🇪🇸 Spain

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Lead and coordinate a cross-functional study team (core and extended) in accordance with SOLID and RACI to ensure study progress and milestone achievement
  • Serve as main liaison between study team and Clinical Program Team (CPT) from handover to close-out and archiving
  • Provide direction, guidance and facilitate communication across functions according to study-specific communication plan
  • For outsourced studies, act as primary sponsor contact for CRO Project Manager and maintain/document CRO oversight
  • Provide input into and hold accountability for development of essential study-level documents from CSP through CSR
  • Ensure external service providers perform to contracted goals and maintain oversight documentation
  • Develop and maintain study plans (e.g. global study management plan, SPP) including quality and risk management planning
  • Oversee study performance against plans, milestones and KPIs using company tracking systems (SPP, CTMS, eTMF dashboards)
  • Identify and report quality issues and collaborate on corrective action plans (CAPAs)
  • Oversee TMF completion and ensure QC activities for TMF completeness
  • Manage study budget re-forecasting and provide budget progress reports to CPT, including financial risks and mitigations
  • Ensure studies are inspection-ready and act as primary LDO Clinical Operations contact for audits/inspections
  • Provide feedback for team members' performance and mentor less experienced colleagues
  • Participate in process improvements and/or lead improvement projects as agreed with manager

Requirements

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
  • 7 years of relevant clinical experience in the pharmaceutical industry
  • Between 2 to 4 years’ project management experience with Global Scope
  • Experience in all phases of a clinical study lifecycle
  • Extensive knowledge of clinical research regulatory requirements (e.g. ICH GCP)
  • Demonstrated abilities in clinical study management processes and clinical/drug development
  • Demonstrated solid project management skills and knowledge of relevant tools
  • Strong team leadership and conflict management skills
  • Ability to establish and maintain effective working relationships with internal and external stakeholders
  • Excellent communication and interpersonal skills
  • Strong strategic and critical thinking, organizational and problem-solving skills
  • Ability to manage competing priorities
  • Must be based in one of the listed locations (Barcelona, Spain; Madrid, Spain; Warsaw, Poland)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
clinical study managementproject managementrisk managementquality managementbudget managementKPI trackingCAPAclinical research regulatory requirementsclinical study lifecycledrug development
Soft skills
team leadershipconflict managementcommunicationinterpersonal skillsstrategic thinkingcritical thinkingorganizational skillsproblem-solvingmentoringstakeholder management