Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können

  • Clinical Operations Project Manager

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

    Join Merz Aesthetics GmbH as a Senior Clinical Project ManagerMerz Aesthetics, a global frontrunner in aesthetic healthcare, is on the lookout for a skilled Senior Clinical Project Manager to enhance their innovative team. As a key player within the esteemed Merz Group, recognized for its superior products, you will play a pivotal role in directing and...

  • Clinical Operations Supervisor

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Otsuka Pharma GmbH Vollzeit

    Otsuka-people dedicated to advancing health solutions globally. With a workforce exceeding 47,000 across 196 subsidiaries, the Otsuka Pharmaceutical Group is committed to innovation. Our mission is to develop groundbreaking products aimed at treating illnesses and promoting well-being. Established in Japan in 1921, Otsuka has achieved numerous significant...

  • Clinical Trial Operations Manager

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland IQVIA Vollzeit

    The IQVIA Clinical Functional Service Partnerships (Clinical FSP) division is dedicated to supporting our client's project teams in the execution of clinical trials. This role offers the chance to collaborate with a single client and oversee clinical research initiatives across various therapeutic areas. We are currently seeking a Local Trial Manager...

  • Lead Clinical Project Manager

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

    Join Merz Aesthetics GmbH as a Senior Manager of Clinical TrialsMerz Aesthetics, a global frontrunner in aesthetic healthcare, is on the lookout for a skilled Senior Manager of Clinical Trials to enhance their innovative team. As a key member of the esteemed Merz Group, recognized for its exceptional offerings, you will play a vital role in directing and...

  • Clinical Site Operations Manager with German

    vor 3 Wochen

    Frankfurt am Main, Deutschland Pharmiweb Vollzeit

    OBJECTIVEThe Clinical Site Operations Manager (CSOM) plays a crucial role in facilitating the execution of clinical studies by identifying and empowering qualified clinical research personnel dedicated to specific studies at research sites. The primary aim is to enhance the efficiency of study deliverables.COLLABORATIONThe CSOM collaborates closely with the...

  • Clinical Finance Operations Manager

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Pharmiweb Vollzeit

    Position Overview:As a prominent global contract research organization (CRO), Pharmiweb is dedicated to scientific excellence and possesses extensive experience in clinical development. We offer a comprehensive suite of clinical development, patient access, and technological solutions across a multitude of therapeutic areas.Role Summary:In the role of...

  • Clinical Operations Manager

    vor 1 Monat

    Frankfurt, Deutschland Otsuka Pharma GmbH Vollzeit

    Otsuka-people creating new products for better health worldwide. More than 47,000 employees worldwide in the 196 companies of the Otsuka Pharmaceutical Group are committed to this. With creativity and a spirit of research, we develop innovative products to treat diseases and maintain health, among other things. Since its foundation in Japan in 1921, Otsuka...

  • Senior Manager for Clinical Research

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

    Join Merz Aesthetics GmbH as a Senior Clinical Project ManagerMerz Aesthetics, a global frontrunner in aesthetic healthcare, is on the lookout for a skilled Senior Clinical Project Manager to enhance their innovative team. As a vital part of the esteemed Merz Group, recognized for excellence in product offerings, you will play a key role in directing and...

  • Senior Manager of Clinical Trials

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

    Join Our Team as a Senior Clinical Project Manager at Merz Aesthetics GmbHMerz Aesthetics, a global frontrunner in the field of aesthetic medicine, is on the lookout for a skilled Senior Clinical Project Manager to enhance our innovative team. As a key member of the esteemed Merz Group, recognized for its superior product offerings, you will play a vital...

  • Clinical Associate

    vor 4 Wochen

    Frankfurt, Deutschland ICON Clinical Research Vollzeit

    Job Advert Posting About the role ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we...

  • Associate Director, Strategic Operations

    vor 3 Monaten

    Frankfurt am Main, Deutschland Novasyte Vollzeit

    Join us on our exciting journey! IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human...

  • Clinical Operations Administrator

    vor 3 Monaten

    Frankfurt am Main, Deutschland Arcondis Vollzeit

    ABOUT ARCONDIS Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and...

  • Senior Clinical Project Manager

    Vor 2 Tagen

    Frankfurt am Main, Hessen, Deutschland APRIORI - business solutions AG Vollzeit

    Project Manager in Clinical ResearchAre you ready to take on a new challenge in the dynamic world of clinical research? If you are passionate about driving impactful clinical trials, have a keen eye for strategic planning, and thrive in an international environment, then this opportunity is perfect for you.Our client, a leading global pharmaceutical company,...

  • Clinical Study Manager

    vor 2 Wochen

    Monheim am Rhein, Deutschland Elanco Animal Health GmbH Vollzeit

    Job Description Clinical Study Manager - Veterinarian - Animal Center Monheim (m/f/d) - The position is an excellent career opportunity for candidates with a strong veterinary background who aspire to gain experience in the global animal health environment POSITION DESCRIPTION As Clinical Study Manager within Clinical Operations Europe, you will play a...

  • Clinical Specialist for Regional Operations

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Blatchford Vollzeit

    Regional Clinical Specialist - BlatchfordBlatchford stands as a leading global entity in the production of prosthetic technology, seating solutions, and orthotic devices, dedicated to enhancing the innovation and wellbeing of its users.We are in search of a Regional Clinical Specialist to enhance our operations in South Germany.Core Responsibilities:Deliver...

  • Clinical Specialist for Regional Operations

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Blatchford Vollzeit

    Regional Clinical Specialist - BlatchfordBlatchford is a leading global entity in the production of prosthetic technology, seating solutions, and orthotic devices, recognized for its dedication to innovation and the well-being of its users.We are in search of a Regional Clinical Specialist to enhance our operations in South Germany.Key...

  • Clinical Specialist for Regional Operations

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Blatchford Vollzeit

    Regional Clinical Specialist - BlatchfordBlatchford stands as a leading global entity in the development of prosthetic innovations, seating solutions, and orthotic devices, dedicated to enhancing the quality of life for users.We are in search of a Regional Clinical Specialist to enhance our operations in South Germany.Core Responsibilities:Deliver...

  • Clinical Specialist for Regional Operations

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Blatchford Vollzeit

    Regional Clinical Specialist - BlatchfordBlatchford stands as a leading entity in the design and production of advanced prosthetic technologies, seating systems, and orthotic solutions, dedicated to enhancing the quality of life for users.We are in search of a Regional Clinical Specialist to enhance our operations in South Germany.Primary...

  • Clinical Project Management Specialist

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH Vollzeit

    Join Our Team as a Senior Clinical Project Manager at Merz Aesthetics GmbHMerz Aesthetics, a global frontrunner in the field of aesthetic medicine, is on the lookout for a skilled Senior Clinical Project Manager to enhance our vibrant team. As a pivotal member of the esteemed Merz Group, recognized for its superior products, you will play a key role in...

  • Veterinary Clinical Research Manager

    vor 3 Wochen

    Monheim am Rhein, Nordrhein-Westfalen, Deutschland Elanco Animal Health GmbH Vollzeit

    Job Overview The position of Clinical Study Manager at Elanco Animal Health GmbH is a remarkable opportunity for individuals with a robust veterinary background who seek to enhance their expertise within the global animal health sector. Role Responsibilities As a Clinical Study Manager in the Clinical Operations Europe team, you will be instrumental in the...

Clinical Operations Manager

vor 1 Monat

Frankfurt am Main, Deutschland Otsuka Pharma GmbH Vollzeit

Otsuka-people creating new products for better health worldwide.

More than 47,000 employees worldwide in the 196 companies of the Otsuka Pharmaceutical Group are committed to this. With creativity and a spirit of research, we develop innovative products to treat diseases and maintain health, among other things. Since its foundation in Japan in 1921, Otsuka has passed through many important milestones and is now a global healthcare group operating in 28 countries with a unique corporate culture that combines Japanese and Western values. An inspiring environment for people who are open to innovation and creativity and want to make a difference together

For Otsuka Pharma GmbH in the department Clinical Operations we are looking for a full-time employee to start as soon as possible as

Manager, Clinical Operations - Monitoring Oversight (m/f/d)


The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate review and reporting of CRO related Key Performance Indicators (KPIs) to the Monitoring Oversight Lead.

  • Manage Monitoring Oversight activities in EU, Africa and Near East regions, and other regions as assigned
  • With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s)
  • Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks
  • Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training)
  • Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead
  • Review OAV reports and manage timelines and deliverables
  • Oversee FSP monitoring resources in assigned region(s) as applicable
  • Support implementation and improvement of monitoring oversight related processes
  • Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs)
  • Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management
  • Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids
  • Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable
  • Ensure compliance with clinical systems use and updates
  • Provide support for internal audit and regulatory inspection activities as applicable
  • Review study specific monitoring plans and provide feedback prior to implementation
  • Collaborate with CMC staffing vendors, as applicable
  • Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget
  • Other monitoring oversight activities as assigned by OPDC Oversight Lead

  • Experience in managing field-based Clinical Research Associates
  • Demonstrated ability to lead teams
  • Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit)
  • Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
  • Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors
  • Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations
  • Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance
  • Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants
  • Possess advanced computer skills (e.g., Microsoft applications, etc.)
  • Financial management skills as applicable to oversee initiatives and system expenditures
  • Ability to handle and prioritize multiple tasks
  • Ability to work effectively in a team/matrix environment
  • Ability to travel up to 30% including ground and air travel

Otsuka Pharma GmbH combines the advantages of a large corporation with those of a small company. We benefit from financial security and infrastructure as well as direct decision-making channels and flat hierarchies. We all know each other personally, work together and support each other - we are a team

In addition to traditional benefits such as a company pension scheme, health allowances and a travel allowance, we also offer you a childcare allowance, the option of additional days off and individual training opportunities.