Project Manager

• Project Leadership and Delivery
  • Lead the planning, execution, and monitoring of multiple complex projects, ensuring alignment with strategic, scientific, and contractual objectives.
  • Develop and maintain project plans, timelines, milestones, and workstreams in collaboration with internal stakeholders and senior leadership.
  • Monitor project progress using project management tools (e.g., Jira, Confluence, MS Teams, SharePoint, Salesforce, Certinia/FinancialForce), identify bottlenecks, and implement mitigation strategies.
  • Ensure the delivery of high‑quality, on‑time project outputs and milestones.
  • Make effective decisions when presented with multiple options and prioritize needs across a portfolio of projects, and communicate regularly with senior leadership to ensure alignment with strategic goals.
  • Use influencing skills to accomplish project goals through people over whom you have no direct authority.
• Client, Partner, and Participant Management
  • Serve as a primary contact for clients, study participants, and contract partners, fostering strong relationships and addressing concerns promptly.
  • Organize, moderate, and document internal and external project meetings.
  • Recruit and coordinate study participants and manage participant‑related communication and contracts.
  • Compile status and final reports for contract partners, internal stakeholders, and senior leadership.
• Clinical, Regulatory, and Quality Responsibilities
  • Support scientific teams in fulfilling contractual obligations and ensure the delivery of high‑quality, on‑time project outputs and milestones.
  • Ensure adherence to quality standards, compliance requirements, and relevant clinical or regulatory guidelines throughout the project lifecycle.
  • Conduct pharmacovigilance activities related to documented treatment data.
  • Research and stay current with relevant clinical guidelines.
  • Prepare and compile documentation for ethics committees and regulatory authorities.
  • Ensure compliance with internal SOPs, regulatory requirements, and applicable guidelines throughout the project lifecycle.
• Cross‑Functional Collaboration
  • Collaborate closely with cross‑functional teams including data management, data analysts, quality management, medical advisors, and vendors to define objectives, deliverables, and timelines.
  • Use influencing skills to accomplish project goals through people over whom you have no direct authority.
  • Coordinate seamlessly across teams to ensure smooth project execution and alignment.
• Process Improvement and PMO Development
  • Conduct post‑project evaluations to identify lessons learned and improvement opportunities.
  • Implement post‑award project management best practices and contribute to the development and revision of SOPs and work instructions.
  • Drive continuous process improvements for project management activities and operational workflows.

• 3+ years of project management experience, ideally in clinical studies, epidemiology, health outcomes, or real-world evidence research.
• Bachelor’s degree in a natural science or comparable education (e.g., medical documentation, Clinical Research Associate training).
• Proficiency with project management methodologies and experience with operational planning and implementation of clinical studies.
• Ideally, you are already familiar with operational planning and implementation of clinical studies
• Proven ability to manage several projects in parallel, with strong prioritization and time-management skills.
• Team spirit, excellent communication, interpersonal, negotiation, and stakeholder‑management skills.
• Experience interacting with clients and providing customer‑focused service.
• Proficiency in MS Office applications, and strong experience with IT and AI solutions.
• Ability to work effectively in a dynamic, agile, and international environment.
• Exceptionally interested in medical topics, affinity to IT, a high degree of initiative and solution-driven approaches.
• Fluency in German and English

Preferred:

• Experience working with healthcare industry clients (pharma) and/or with healthcare data strongly preferred. 
• Ability to quickly deep‑dive into new topics and interest in developing expertise in healthcare data analysis environments (e.g., GxP).
• Knowledge of outcomes research, healthcare data, or epidemiology.
• Experience with submissions to ethics committees or regulatory authorities.
• PMP certification or equivalent.
• Language skills additional to German and English are beneficial but not essential.
• Familiarity with GCP, the Declaration of Helsinki, or National Medicinal Products Act, especially the German AMG.
• Familiarity with secuTrial® or other EDC systems.