Clinical Operations Manager

vor 2 Wochen

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 pre-award/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 multi-regional and multi-protocol programs during initial start-up 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 in-depth 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 co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities.

  • Clinical Operation Manager

    vor 2 Wochen

    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 4 Wochen

    Wien, Österreich Johnson & Johnson Vollzeit

    Über Johnson & Johnson - Janssen Seit 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...

  • Local Clinical Operations Manager

    vor 2 Wochen

    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 2 Wochen

    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 Operations Manager

    vor 2 Wochen

    Wien, Österreich Valneva Vollzeit

    **Responsibilities** - Responsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission. - Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable. - Ensures all operational study deliverables are met according to timelines,...

  • Clinical Operations Manager

    vor 2 Wochen

    Wien, Wien, Österreich IQVIA Vollzeit

    Job OverviewDirect 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...

  • Clinical QA Manager

    vor 2 Wochen

    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 2 Wochen

    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 Operations Manager

    vor 3 Wochen

    Wien, Österreich Valneva Vollzeit

    or only-in-class vaccine solutions. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. **Responsibilities**: - Responsible for all aspects of one or more...

  • Clinical Research Manager

    Vor 3 Tagen

    Wien, Österreich Johnson & Johnson Vollzeit

    (Senior) Clinical Research Manager (m/w/x) Location: Vienna, Austria We 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...

  • Clinical Team Manager

    vor 2 Wochen

    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 2 Wochen

    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 Trial Manager

    vor 3 Wochen

    Wien, Österreich globe personal services GmbH Vollzeit

    As a personal service company, we specialize in connecting our clients with the most qualified individuals and identifying the most suitable job opportunities for you! The company is currently expanding its team and is eager to welcome new members. Through its work in biotechnology and pharmaceuticals, it has significantly improved the lives of numerous...

  • (Senior/principal) Clinical Team Manager

    vor 3 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Hematology and Oncology** 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...

  • (Senior/principal) Clinical Team Manager

    vor 4 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Neuroscience** 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...

  • (Senior/principal) Clinical Team Manager

    vor 4 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Neuroscience** 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...

  • (Senior/principal) Clinical Team Manager

    vor 4 Wochen

    Wien, Österreich Thermo Fisher Scientific Vollzeit

    **(Senior/Principal) Clinical Team Manager - Infectious and Respiratory Diseases** 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...

  • Clinical Project Manager

    vor 2 Wochen

    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 4 Wochen

    Wien, Österreich PSI CRO Vollzeit

    **Company Description** PSI 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...

  • Clinical Project Manager

    Vor 2 Tagen

    Wien, Österreich PSI CRO Vollzeit

    **Company Description** PSI 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...