Clinical Operations Manager

vor 1 Woche

Wien, Wien, Österreich IQVIA Vollzeit

Job Overview

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.


Essential Functions

  • Oversee the execution of Site Activation (including preaward/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
  • Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
  • Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
  • Provide overall guidance and oversight of multiregional and multiprotocol programs during initial startup and maintenance phase as an integral member of the study management team.
  • Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
  • Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
  • Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.
  • Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
  • Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
  • May take a lead role in developing long standing relationships with preferred IQVIA customers.
  • Deliver presentations/training to clients, colleagues and professional bodies, as required.
  • May be involved in activities related to monthly study budget planning and reviews.

Qualifications

Bachelor's Degree Life sciences or related field Req

7 years' relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.

  • Strong negotiation and communication skills with ability to challenge.
  • Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
  • Thorough understanding of regulated clinical trial environment and indepth knowledge of drug development process
  • Good regulatory and/or technical writing skills
  • Good leadership skills, with ability to motivate, coach and mentor.
  • Good organizational and planning skills
  • Ability to exercise independent judgment taking calculated risks when making decisions.
  • Proven ability to establish and maintain effective working relationships with coworkers, managers and sponsors.
  • Excellent understanding of study financial management
  • Proven ability to work on multiple projects balancing competing priorities.

  • Clinical Operation Manager

    vor 1 Woche

    Wien, Wien, Österreich MSD Vollzeit

    Job Description:We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Local Clinical Operations Manager

    vor 1 Woche

    Wien, Wien, Österreich Johnson & Johnson Vollzeit

    Über Johnson & Johnson - JanssenSeit über 130 Jahren gehören Diversity, Equity & Inclusion (DEI) zu unserer Unternehmenskultur bei Johnson & Johnson. Sie sind ein Grundprinzip unseres täglichen Handelns. Die Würde und Vielfalt aller Menschen zu respektieren, ist eine Verpflichtung, die wir fest in unserem Credo verankert haben. Wir wissen: Um...

  • Clinical Operations Manager

    vor 1 Woche

    Wien, Wien, Österreich Octapharma Vollzeit

    Job ID: Location: Wien, AT- Job Level: Professionals- Job Category: Research and Development- Employment Type: Permanent position- Career Level:Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a...

  • Clinical QA Manager

    vor 1 Woche

    Wien, Wien, Österreich Hobson Prior Vollzeit

    Hobson Prior are looking for a Clinical QA Manager to join a brilliant pharmaceutical corporation on a permanent basis located either in Germany or Austria. Our client is focused on developing remedies from high-quality human proteins.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities: For...

  • Regional Clinical Trial Manager

    vor 1 Woche

    Wien, Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

    THE POSITION:For our Regional Therapeutic Area Management Group in Clinical Development & Operations we are looking for a Clinical Trial Manager (f/m/d) with an emphasis on inflammation/immunology, CNS and oncology. You will provide operational expertise to manage and oversee clinical trials conducted in different therapeutic areas that are under the...

  • Clinical Team Manager

    vor 1 Woche

    Wien, Wien, Österreich PPD Vollzeit

    JOB DESCRIPTION:(Senior/Principal) Clinical Team Manager - Infectious and Respiratory DiseasesAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the...

  • Clinical Research Manager

    vor 1 Woche

    Wien, Wien, Österreich Johnson & Johnson Vollzeit

    (Senior) Clinical Research Manager (m/w/x)Location: Vienna, AustriaWe are looking for a driven (Senior) Clinical Research Manager to join our growing Clinical Operations team in Austria and Switzerland. The alpine countries are embedded and organized in a D-A-CH concept with Germany completing the cluster of countries. We are conducting the rich portfolio of...

  • Clinical Project Manager

    vor 1 Woche

    Wien, Wien, Österreich PSI CRO Vollzeit

    Job DescriptionTake your career to the next level and lead challenging full-service global clinical research projects, managing the full scope of responsibilities and getting hands-on involvement in every aspect of the study.Remote of HybridYour responsibilities will include:Management of global, multi-center clinical research projects in a variety of...

  • Clinical Project Manager

    vor 1 Woche

    Wien, Wien, Österreich PSI CRO Vollzeit

    Company DescriptionPSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new...

  • Associate Clinical Operations Manager

    vor 1 Woche

    Wien, Wien, Österreich Valneva Vollzeit

    Responsibilities: Proactive support of all aspects of one or more phase 14 clinical studies Support in the implementation of clinical studies from startup to study completion Contribution to the development of study relevant documents in the project development cycle Support in CRO/vendor selection process and CRO/vendor oversight Monitoring and execution of...

  • Associate Clinical Operation Manager

    vor 1 Woche

    Wien, Wien, Österreich Valneva Vollzeit

    Proactive support of all aspects of one or more phase 1-4 clinical studies Support in the implementation of clinical studies from startup to study completion Contribution to the development of study relevant documents in the project development cycle Support in CRO/vendor selection process and CRO/vendor oversight Monitoring and execution of all study...

  • Senior Clinical Study Assistant

    vor 1 Woche

    Wien, Wien, Österreich Labcorp Vollzeit

    The Senior Clinical Study Assistant (CSA) will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. Provide support for critical daytoday clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the...

  • Eu - Clinical Project Manager (Cpm)

    vor 1 Woche

    Wien, Wien, Österreich Celerion Vollzeit

    One of our key assets and greatest resources is the experience and expertise of our employees.We are looking for a (Senior) Clinical Project Manager (M/F)in Vienna, AustriaThe main aim of the (Senior) Clinical Project Manager (CPM) is the operational management of studies or projects managed by Celerion.Essential Functions Perform operational management...

  • Regional Clinical Trial Coordinator

    vor 1 Woche

    Wien, Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

    The position:For our Trial Coordination Management Team (TCM) in our Clinical Development & Operations Department we are seeking for a Regional Clinical Trial Coordinator, who is responsible for coordinating, supporting, and liaising with regional and global stakeholders to make sure the trials are successfully conducted in our region.Tasks &...

  • Associate Clinical Supply Chain Manager

    vor 1 Woche

    Wien, Wien, Österreich Novasyte Vollzeit

    Job OverviewThe Associate Clinical Supply Chain Manager ensures the on-time delivery of supplies (Investigational Medicinal Products and Non-Investigational Medicinal Products) to clinical sites for established clinical trials contracted to IQVIA. This is achieved through effective inventory monitoring, ongoing forecasting of drug demand, initiation and...

  • Clinical Research Manager

    vor 1 Woche

    Wien, Wien, Österreich MSD Vollzeit

    Job Description:We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...

  • Head of Operations

    vor 1 Woche

    Wien, Wien, Österreich Talentor Sweden AB Vollzeit

    Our client is a specialized player in the life science sector and a leader in his field. The company is characterized by its dynamic environment, innovative approach, and team spirit.The following business-critical leadership position is to be filled with immediate effect:Head of Operations / Deputy Head of Department (f/m/x)Location: ViennaYOUR FUTURE ROLE...

  • Principal Clinical Data Manager

    vor 1 Woche

    Wien, Wien, Österreich Labcorp Vollzeit

    Principal Clinical Data Manager - Late Phase (EMEA - home or office based)As an experienced Principal Clinical Data Manager in our Late Phase (IIb-III-IV) multi-sponsor business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. you will work alongside the...

  • Clinical Research Associate

    vor 1 Woche

    Wien, Wien, Österreich Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Clinical Trial Coordinator

    vor 1 Woche

    Wien, Wien, Österreich MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...