Senior Manager Clinical Operations

vor 24 Stunden

Bad Homburg EK, Deutschland Fresenius Vollzeit 90.000 € - 120.000 € pro Jahr
Your responsibilities:
  • Planning, organization, execution, oversight and evaluation of national and international clinical trials (Phase I-IV, focus on nutrition clinical studies) according to ICH-GCP, other applicable legislations and internal standard operating procedures (SOPs). This includes the following tasks:
  • Management of clinical studies according to target market (EU/US/PhM) requirements
  • Develop detailed project plans, timelines, and budgets estimates for clinical trials and bioequivalence studies
  • Selection, instruction and supervision of Contract Research Organizations (CROs)/study sites and collaboration with external service providers (e.g. consultants, medical experts)
  • Cross functional collaboration with central functions (Regulatory Affairs, Pharmacovigilance/Drug Safety, Drug Supply and QA etc.)
  • Design, development, review of clinical study protocol, CRF and study report, etc
  • Review of analytical method validation and analysis documents
  • Support in compilation of regulatory documents, including clinical trial applications (CTAs) and amendments
  • Response to queries received from regulatory authorities and ethic committees
  • Ensure compliance to applicable regulatory requirements and standards
  • Monitoring/co-monitoring and supervision of study sites and ensure data integrity and accuracy
  • Set up, review and maintenance of trial master file (e)TMF
  • Safeguarding the study documentation
  • Generation of monthly status reports according to internal reporting system
Your profile:
  • Master's degree in life sciences, pharmacy, or a related field. Advanced degree (e.g., PhD) is preferred
  • At least 5 years of experience as clinical trial manager (preferably at sponsor end) with strong expertise in phase-IV studies
  • Hands on experience with project management tools or certification will be preferred
  • Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials and bioequivalence studies
  • Proficiency in Microsoft Office tools. Experience in clinical trial management software is plus
  • Excellent project management skills, including the ability to manage multiple projects simultaneously
  • Ability to work effectively in international teams and matrix organization with multi-disciplinary teams
  • Excellent communication skills, spoken and written (English)

Mindesteingruppierung/Minimum Grading:

AT (K)

  • Manager Operations

    vor 1 Woche

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 10.000 € pro Jahr

    Wir sind der Vorstandsbereich Legal, Compliance, Risk Management, Sustainability, Human Resources, Corporate Audit und Fresenius Vamed und suchen Sie als Unterstützung für unsere Head of Operations. In dieser spannenden Position bieten sich Ihnen viele Möglichkeiten: Aus der Natur dieser vorstandsnahen Tätigkeit sowie der damit verbundenen Zusammenarbeit...

  • Senior Manager Medical-Scientific Intelligence and IITs

    vor 1 Tag

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 80.000 € - 120.000 € pro Jahr

    You main tasks:Define, explore and develop innovation areas to open future growth fields for Fresenius KabiIdentify and analyse medical trends, needs, new developments as well as competitor activities in nutrition science and adjacent fieldsConduct in-depth reviews of new scientific publications and other public information to spot trends and potential...

  • Senior Manager Medical-Scientific Intelligence and IITs

    vor 20 Stunden

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 90.000 € - 120.000 € pro Jahr

    You main tasks:Define, explore and develop innovation areas to open future growth fields for Fresenius KabiIdentify and analyse medical trends, needs, new developments as well as competitor activities in nutrition science and adjacent fieldsConduct in-depth reviews of new scientific publications and other public information to spot trends and potential...

  • Business Operations and Execution Manager, iMRI

    vor 1 Tag

    Bad Oldesloe, Schleswig-Holstein, Deutschland Cook Medical Vollzeit 90.000 € - 120.000 € pro Jahr

    The Business Operations and Execution Manager (BOEM) Europe is a key member of the iMRI commercialization team and is responsible for driving procedural adoption and supporting capital equipment sales efforts. This role focuses on guiding healthcare providers and key decision-makers through the adoption process of Cook Medical's iMRI suite, ensuring clinical...

  • Senior) Associate

    vor 2 Wochen

    Bad Homburg vor der Höhe, Deutschland Lilly Vollzeit

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • (Senior) Associate – Quality Assurance Clinical Trials

    vor 4 Wochen

    Bad Homburg, Deutschland Careforce GmbH Vollzeit

    Careforce ist der Personalberater der Healthcare Industrie. Seit mehr als 20 Jahren unterstützen wir Unternehmen dabei, die richtigen Spezialisten zu finden. Im Auftrag suchen wir für unseren Kunden suchen wir eine/n (Senior) Associate – Quality Assurance Clinical Trials (m/w/d) Unternehmenssitz: Region Frankfurt am Main ( hybrid, d. h. regelmäßige...

  • Senior Project Manager Commercial Applications

    vor 2 Wochen

    Bad Homburg (H-), Deutschland Fresenius Kabi Vollzeit 80.000 € - 120.000 € pro Jahr

    Position OverviewAs Senior Project Manager Commercial Applications, you will lead and deliver complex, large-scale IT transformation projects across Fresenius Kabi's global Commercial Applications landscape.You will oversee the full project lifecycle—from strategic planning to execution and closure—ensuring on-time delivery, budget adherence, and...

  • Manager MedTech FP&A

    Vor 7 Tagen

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 60.000 € - 120.000 € pro Jahr

    As a Manager FP&A & Analytics (m/f/d) for MedTech, you will play a key role in driving financial performance and enabling data-driven decisions in a global healthcare environment. You will lead FP&A processes for EBIT, cash flow, and net working capital, modernize reporting tools, and provide actionable insights that shape strategic outcomes.Your...

  • Manager Redenschreiber

    Vor 6 Tagen

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 60.000 € - 80.000 € pro Jahr

    (Senior)ManagerRedenschreiber (m/w/d) für Vorstand und AufsichtsratDie Unternehmenskommunikation der Fresenius SE & Co KGaA leistet einen wichtigen Beitrag zur Positionierung und zum Ansehen des Unternehmens. Das Team "Speeches & Thought Leadership" der Unternehmenskommunikation sucht ab sofort Verstärkung. Wir suchen einen Redenschreiber (m/w/d) für den...

  • Manager Redenschreiber

    vor 23 Stunden

    Bad Homburg (EK), Deutschland Fresenius Vollzeit 60.000 € - 90.000 € pro Jahr

    (Senior)ManagerRedenschreiber (m/w/d) für Vorstand und AufsichtsratDie Unternehmenskommunikation der Fresenius SE & Co KGaA leistet einen wichtigen Beitrag zur Positionierung und zum Ansehen des Unternehmens. Das Team "Speeches & Thought Leadership" der Unternehmenskommunikation sucht ab sofort Verstärkung. Wir suchen einen Redenschreiber (m/w/d) für den...