Medical Monitor

vor 1 Woche

Munich, Deutschland PSI CRO Vollzeit

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:
PSI **Medical Monitors **provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

**Responsibilities**:

- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
- Address safety issues across the study from sites and the study team
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.

**Qualifications**:

- Medical Doctor degree
- Oncology board certification is a must
- Prior and wide experience as a practicing Oncologist
- Full working proficiency in English
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented

Additional Information

As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

  • Medical Monitor

    vor 2 Wochen

    Munich, Bayern, Deutschland PSI CRO Vollzeit

    Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we...

  • Medical Monitor

    vor 2 Wochen

    Munich, Deutschland PSI CRO Vollzeit

    Job DescriptionPSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.Responsibilities:Advise clients, project teams, sites, regulatory agencies and third-party vendors on medical mattersCollaborate with internal departments in the...

  • Senior Medical Affairs Specialist

    vor 1 Woche

    Munich, Bayern, Deutschland Insulet Corporation Vollzeit

    Job Title:Sr. Medical Affairs Specialist, Global Medical CommunicationsOur CompanyInsulet Corporation is an innovative medical device company dedicated to simplifying the lives of people living with diabetes. Founded in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives using our Omnipod product...

  • Head of Medical Affairs Oncology

    vor 2 Wochen

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: **Head of Medical Affairs Oncology (M/F/x)**: **The position**: The Head of Medical Affairs Oncology (M/F/x) leads the development and execution of the European medical strategies for Daiichi-Sankyo’s Oncology Business Unit portfolio. Responsible for maximizing Daiichi Sankyo‘s value proposition of...

  • Head Medical Innovation

    vor 2 Wochen

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    The Head of Medical Innovation & Digital Strategy is responsible for developing, implementing and overseeing European and local Medical & Digital strategies for the indication areas within the DS Specialty Business Division. She/he will work closely with the other SBD Medical Affairs as well as cross-functional roles (especially with the Digital Excellence...

  • Key Account Manager

    vor 1 Tag

    Munich, Deutschland Merit Medical Systems Inc Vollzeit

    Job Description The Key Account Manager is responsible for TOP 20 Accounts and TOP Private Hospital Groups in Germany. ESSENTIAL FUNCTIONS PERFORMED Identify and prioritise opportunities as aligned with customer strategy. Coordinate account team activities and resources ( CI, PI, MMX). Responsible for c-suites relationships. Respond to customer concerns....

  • Senior Quality Management and Regulatory Affairs Manager

    Vor 3 Tagen

    Munich, Bayern, Deutschland ImFusion GmbH Vollzeit

    Your missionImFusion is an independent R&D company based in Munich. We help our customers to drive innovation in Medical Imaging based on our software platform for Image Processing, Computer Vision, AI and Robotics. We wish to expand our team with talented and motivated people to help us develop and commercialize advanced medical products in collaboration...

  • Senior Quality Management and Regulatory Affairs Manager

    vor 1 Woche

    Munich, Bayern, Deutschland ImFusion Vollzeit

    Your mission ImFusion is an independent R&D company based in Munich. We help our customers to drive innovation in Medical Imaging based on our software platform for Image Processing, Computer Vision, AI and Robotics. We wish to expand our team with talented and motivated people to help us develop and commercialize advanced medical products in collaboration...

  • Executive Director Disease Area Strategy Team Lead

    vor 2 Wochen

    Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    Disease Area Strategy Team (DAST) is a highly matrixed cross-functional and cross-regional team including R&D, commercial and Medical Affairs functions. The two DAST teams are tasked to monitor changes and trends in the therapeutic landscape of Breast Cancer or Lung Cancer and provide end-to-end strategic leadership and disease area expertise across the ADCs...

  • Surgical Nurse

    vor 2 Wochen

    Munich, Bayern, Deutschland Rectrade ProSkill Connect Vollzeit

    Are you an experienced Surgical Nurse (OP-Pflegekraft) looking for a new opportunity in Munich? Join our client, where you will work in a state-of-the-art surgical department, assisting in life-changing procedures and ensuring the highest level of patient care.This role is ideal for experienced surgical nurses, operating room specialists, and internationally...