Clinical Project Manager -Non Interventional Studies - Sponsor Dedicated (m/f/w)

Job Overview

Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and IQVIA's suite of solutions to drive operational excellence and strategic leadership with our customers.

Essential Functions

• Support Medical Affairs and CRO in the operational planning and launch of non-interventional studies.
• Coordinate study start-up activities including:
  • Site identification and feasibility
  • Site onboarding and documentation
  • Study documentation management
  • Contracting and Site Management
  • Lead and coordinate the contracting process for approximately 100 dermatology sites.
  • Collaborate with Legal, Procurement, and Finance to prepare and execute site agreements.
  • Track contracting status and ensure timely execution.
  • Maintain a central tracker for site contracts, budgets, and study payments.
• Vendor and CRO Coordination
  • Act as operational liaison with external partners including:
  • Contract research organizations (CROs)
  • Data management vendors
  • Study support providers
  • Monitor vendor deliverables, timelines, and operational milestones.
• Cross-Functional Coordination
  • Serve as the operational coordinator between Medical Affairs, Legal, Compliance, Procurement, and external vendors.
  • Facilitate internal meetings and ensure alignment on timelines and deliverables.
  • Track study progress and escalated operational risks where necessary.
• Study Tracking and Reporting
  • Develop and maintain study trackers including:
  • Site onboarding status
  • Contracting progress
  • Budget tracking
  • Study milestones
  • Provide regular updates to Medical Affairs leadership.

Qualifications

• Bachelor's Degree in Life Sciences or related field – Requirement
• 5 years of prior relevant experience including >3 years project management experience or equivalent combination of education, training and experience – Requirement
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience – Requirement
• Must have experience managing observational / phase IV / non-interventional studies
• Must have experience managing Dermatology chronic inflammatory diseases trials
• Knowledge of clinical trials: clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge; therapeutic knowledge desired. Good understanding of the competitive environment and how to communicate and demonstrate value through IQVIA solutions.
• Communication – Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving – Strong problem solving skills.
• Leadership – Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership – Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organisation – Planning, time management and prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritisation – Ability to handle conflicting priorities.
• Quality – Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality – Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• T skills – Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration – Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration – Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances – Good understanding of project financials including experience managing contractual obligations and implications.
• IQVIA Core Competencies – Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).
• Hybrid role : working partially from home and from sponsor offices in Munich