Clinical Systems Manager Stellenangebote

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Stellenangebote Clinical Systems Manager Jobs bei Stellenanzeigen.de

Job vor 8 Tagen gefunden eleva GmbH

IP Manager/ Patent Manager (m/f/d)

• 79098, Freiburg im Breisgau, Deutschland Jobticket

MEHR

[...] its foundation in 1999, the company has developed a moss- based technology platform that enables the production of complex proteins for the treatment of various diseases, some of which are rare and underserved. In addition, Eleva has successfully completed a clinical trial with a moss- based biopharmaceutical and is planning the second clinical trial. Our team currently consists of ca. 50 [...] to our friendly and straightforward corporate culture. With their work, our employees make a difference in the development of new therapies for patients around the world. We are looking for you to join our team as soon as possible: IP Manager/ Patent Manager (m/f/d) 50 part time, permanent, fully remote or hybrid What you should be excited about As IP Manager [...] managing our patent portfolio, you ll help secure and maximize the value of our most important inventions. Acting as a vital link between our inventors and external patent attorneys, you ll ensure smooth communication and keep our filing and monitoring systems organized for easy access. As an ISO- certified company, we work according to quality guidelines, and you support your team [...]
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Job vom 30.10.2024 Bruker Physik GmbH SAP Inhouse Consultant Mm/wM/ QM (m/f/d) • 76275, Ettlingen, Deutschland Beratungs-/ Consultingtätigkeiten

MEHR

[...] of our locations: Ettlingen in Germany or Porto in Portugal for a full- time position with potential for Solution Architect, as a Tasks/ Responsibilities: Act as a project team member or work stream lead with reporting line to the SAP Manager Logistics Operations Implement SAP solutions (customizing, functional testing, training, etc. ) in S/ 4HANA for MM/ Stockroom Management/ QM Contribute [...] applied and pharma applications, in microscopy and nanoanalysis, as well as in industrial applications. Today, worldwide more than 8, 500 employees are working on this permanent challenge at over 90 locations. Bruker offers differentiated, high- value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single- cell biology, functional structural and condensate biology, as well as in clinical [...]
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Stellenangebote Clinical Systems Manager Jobs bei Jobleads

Job vom 13.10.2024

Drug Product Manager (Reporting to the Vice President CMC IP)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Drug Product Manager (Reporting to the Vice President CMC IP) As a Drug Product Manager, you will be part of our CMC management drug product team supporting all clinical projects with respect to product quality, CMO management, and CMC documentation for regulatory dossiers. Your mission As a Drug Product [...] flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. Ai Curis, with its expertise and growing pipeline, [...]
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Job vom 26.09.2024 Senior Director (m/f/d) Medical Affairs Germany • Ulm, Baden- Württemberg Führungs-/ Leitungspositionen

MEHR

[...] a look: Location of the role This position is based in Ulm, Germany. A day in Medical Affairs As the Head of Medical Affairs- Germany, your primary role is to provide overall Medical leadership through alignment with the Germany General Manager and Regional Medical VP. We see this role as a strategic partner to Commercial teams, Market Access teams and other [...] the innovative pharma business, with a proven track record of successful launches of innovative products in the German market. Knowledge of the AMNOG procedure is essential. deep understanding of reimbursement and payer landscape in Germany. Strong knowledge of German healthcare systems and GBA processes proven experience managing medical affairs teams covering diverse therapeutic areas; experience in Neurology, Psychiatry, Gastroenterology (IBD) , Immunology or Immuno- oncology areas would be preferred but not mandatory. solid understanding of clinical trial execution and experience in driving German site identification as well as patient recruitment acceleration is strongly preferred. excellent communication [...]
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Job vom 18.09.2024

Site Care Partner I- (, , Remote)

MEHR

[...] coordination of site activation checklist items, ICD finalization, SIV (as applicable) , including management of issues that may compromise time to site activation. Ensure all the site initiation activity including training per site activation checklist, collect and/ complete necessary documentation/ systems needed for site activation. (e. g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/ eISF etc. ) Support country specific [...] delivery including issue resolution of decentralized capabilities at investigator sites e. g. home health, ePRO, DTP etc. Assure quality and consistency in the delivery of monitoring Drive monitoring efficiencies and best practices for study/ region/ program Support shaping the local clinical development environment with a goal to enhance client reputation in scientific leadership. May act as a Subject Matter Expert on [...] systems and processes. Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/ site satisfaction and strengthen site relationships Ensures clear and open communication with Study Operations Manager Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or [...]
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Job vom 08.09.2024 Site Care Partner- All US Locations- FSP- (, , Remote)

MEHR

[...] input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) . Provide country/ regional level input to country strategy, feasibility, and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required. Maintain a thorough knowledge of assigned protocols Conduct study start up activities at the site level including [...] coordination of site activation checklist items, ICD finalization, SIV (as applicable) , including management of issues that may compromise time to site activation. Ensure all the site initiation activity including training per site activation checklist, collect and/ complete necessary documentation/ systems needed for site activation. ( e. g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/ eISF etc. ) Support country [...] systems and processes. Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/ site satisfaction and strengthen site relationships Ensures clear and open communication with Study Operations Manager Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or [...]

Job vom 25.08.2024

Senior Director (m/f/d) Medical Affairs Germany

• Ulm, Baden- Württemberg Führungs-/ Leitungspositionen

MEHR

[...] our team Location of the role This position is based in Ulm, Germany. A day in Medical Affairs As the Head of Medical Affairs- Germany, your primary role is to provide overall Medical leadership through alignment with the Germany General Manager and Regional Medical VP. We see this role as a strategic partner to Commercial teams, Market Access teams and other [...] the innovative pharma business, with a proven track record of successful launches of innovative products in the German market. Knowledge of the AMNOG procedure is essential. deep understanding of reimbursement and payer landscape in Germany. Strong knowledge of German healthcare systems and GBA processes proven experience managing medical affairs teams covering diverse therapeutic areas; experience in Neurology, Psychiatry, Gastroenterology (IBD) , Immunology or Immuno- oncology areas would be preferred but not mandatory. solid understanding of clinical trial execution and experience in driving German site identification as well as patient recruitment acceleration is strongly preferred. excellent communication [...]

Job vom 01.08.2024 Site Care Partner- FSP- (, , Remote)

MEHR

[...] coordination of site activation checklist items, ICD finalization, SIV (as applicable) , including management of issues that may compromise time to site activation. Ensure all the site initiation activity including training per site activation checklist, collect and/ complete necessary documentation/ systems needed for site activation. (e. g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/ eISF etc. ) Support country specific [...] delivery including issue resolution of decentralized capabilities at investigator sites e. g. home health, ePRO, DTP etc. Assure quality and consistency in the delivery of monitoring Drive monitoring efficiencies and best practices for study/ region/ program Support shaping the local clinical development environment with a goal to enhance Client reputation in scientific leadership. May act as a Subject Matter Expert on [...] systems and processes. Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/ site satisfaction and strengthen site relationships Ensures clear and open communication with Study Operations Manager Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or [...]

Stellenangebote Clinical Systems Manager Jobs bei StepStone

Neu Job vor 6 Std. gefunden Immatics Biotechnologies GmbH

Senior Manager Clinical Quality Assurance (m/w/d)

• bundesweit Homeoffice möglich Jobticket

MEHR

Immatics Biotechnologies GmbH sucht in bundesweit eine/n Senior Manager Clinical Quality Assurance (m/w/d) (ID- Nummer: 11739481) . Immatics combines the discovery of true targets for cancer immunotherapies with the development [...] as well as your organization and communication skills will contribute to the teams success. Your mission Your main responsibilities will include but are not limited to the following tasks: Support of the implementation and maintenance of clinical QA processes and systems Maintenance of the clinical eQMS component including the definition, generation, and interpretation of quality metrics and trending reporting Creation or [...]

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Weitere Stellenangebote Clinical Systems Manager bei StepStone

Job vor 5 Tagen gefunden Daiichi Sankyo Europe GmbH Senior Manager Clinical Trial Office (m/f/x) - 20h per week • München Teilzeit Work-Life-Balance

MEHR

Daiichi Sankyo Europe GmbH sucht in München eine/n Senior Manager Clinical Trial Office (m/f/x) - 20h per week (ID- Nummer: 11723581) . With over 120 years of experience and more than [...] and anything related to the CTR Become an expert in Clinical Trial Information System (CTIS) and support and guide study teams and other users Keep current with review and interpret Daiichi Sankyo procedures, Daiichi Sankyo internal and external tools and systems and key regulatory regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders Education Experience Education [...]

Job vom 05.11.2024 bess AG

Clinical Affairs Manager (m/w/d)

• Berlin Teilzeit

MEHR

bess AG sucht in Berlin eine/n Clinical Affairs Manager (m/w/d) (ID- Nummer: 11676358) . The bess group is a medium- sized, owner- managed business with an international presence, manufacturing sites in Berlin (Germany) , the United States and France, and around 140 members of staff. As manufacturers and distributors of implants, instruments and innovative device systems, we serve clients across the fields of ENT, head and neck surgery, pulmonology and gastroenterology. For over 30 years, we [...]
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Job vom 02.11.2024 Bruker Physik GmbH SAP Inhouse Consultant Mm/wM/ QM (m/f/d) • Porto, Ettlingen Beratungs-/ Consultingtätigkeiten

MEHR

[...] applied and pharma applications, in microscopy and nanoanalysis, as well as in industrial applications. Today, worldwide more than 8, 500 employees are working on this permanent challenge at over 90 locations. Bruker offers differentiated, high- value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single- cell biology, functional structural and condensate biology, as well as in clinical [...] in Germany or Porto in Portugal for a full- time position with potential for Solution Architect, as a SAP Inhouse Consultant Mm/wM/ QM (m/f/d) Act as a project team member or work stream lead with reporting line to the SAP Manager Logistics Operations Implement SAP solutions (customizing, functional testing, training, etc. ) in S/ 4HANA for MM/ Stockroom Management/ QM Contribute [...]

Job vom 02.11.2024 FUTRUE GmbH

Manager Clinical Trials Data Management Statistics (w/m/d)

• Gräfelfing bei München Homeoffice möglich

MEHR

FUTRUE GmbH sucht in Gräfelfing bei München eine/n Manager Clinical Trials Data Management Statistics (w/m/d) (ID- Nummer: 11654178) . Vertanical ist ein hochinnovatives Biopharmaunternehmen, das sich auf die Entwicklung einzigartiger [...] die Entwicklung von klinischen Studienprotokollen verantwortlich. Du koordinierst die Auswahl von und die Zusammenarbeit mit Dienstleistern (CROs) für Datenmanagement und Biostatistik. Dein Fokus liegt dabei auf der gemeinsamen Entwicklung von Datenmanagement- und Datenvalidierungsplänen. Du beaufsichtigst die Programmierung des Data- Entry- Systems und führst User- Acceptance- Tests durch. Du definierst gemeinsam mit den CROs die Strategie für die statistische Analyse der klinischen [...]

Job vom 21.09.2024 ZEISS Quality Manager Specialist (f/m/x) • München

MEHR

ZEISS sucht in München eine/n Quality Manager Specialist (f/m/x) (ID- Nummer: 11513769) . Step out of your comfort zone, excel and redefine the limits of what is [...] of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. Apply now It takes less than 10 minutes. Support of quality management activities in an interdisciplinary and cross- location project team for software systems running on medical devices or medical software- only products, as advisor and supporter of the project manager and the project [...] Carry out complaint management and, if necessary, support initiating reports to authorities and management Contribute to the post- market- surveillance activities needed for the product. Work closely with colleagues from Quality Management, Development, Product Management, Information Security and Regulatory and Clinical Affairs Degree in computer science, business administration or comparable degree Several years of professional experience in software development or in [...]

Job vom 12.09.2024 ZEISS

Manager Business Sector Clinical (f/m/x)

• München, Jena

MEHR

ZEISS sucht in München, Jena eine/n Manager Business Sector Clinical (f/m/x) (ID- Nummer: 11234062) . Step out of your comfort zone, excel and redefine the limits of what is possible. [...] clinical and edical microscopy sector Academic background in natural sciences/ biomedical or a clinical/ medical background is desired. PhD/ MD would be advantageous Minimum of 3 years of experience in sales, product/ solution marketing, business development of biomedical microscopy/ medical Systems Proven experience in successfully managing difficult negotiations and working in multicultural environments Innovative bent of mind and strong bias for [...]

Stellenangebote Clinical Systems Manager Jobs bei Jobware

Job vom 13.09.2024 Fresenius Kabi Intern (m/f/d) Subsidiary Management Transfer Pricing • Bad Homburg

MEHR

[...] Tax, the regions/ business units as well as with the worldwide subsidiaries) Your expertise is in demand Current studies in business administration, economics, commercial law or similar, ideally with a focus on controlling or taxation Initial experience with business warehouse systems (SAP BW) as well as Share Point, would be an advantage Very good knowledge of MS Office, especially Excel and [...] and improving the quality of life of patients: that s Fresenius Kabi. Get involved and contribute your ideas to the development of groundbreaking products, services and therapies for the care of critically and chronically ill patients. Isabell Kuhn (Junior HR Manager) Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. fresenius- kabi. com We [...]
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Stellenangebote Clinical Systems Manager Jobs bei Freelance.de

Job vom 24.10.2024

Für Freelancer- Local Qualified Person for Pharmacovigilance (LQPPV) (gn)

• DACH Region Freiberuflich

MEHR

[...] for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections. - Ensuring business continuity and in case of absence ensuring back- up/ deputy coverage is in place - Ensure awareness of relevant functions (e. g. regulatory affairs, clinical, QA) within client affiliate organisation and promote pharmacovigilance at local country level. - Respond fully and promptly to requests from [...] lead by example; assist management with allocating resources to projects. Will be required to work independently within the QPPV role. - Proactively identify issues and propose solutions. Respond promptly and effectively to all requests. - Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns; participate in project review meetings with management; communicate and document project [...] tasks and responsibilities. - Notify the MAH and/ or EU QPPV (where applicable) of emerging signals of safety concerns. - Maintains awareness of sources and channels for communication of safety information received at country level. - Ensures that processes and systems are in place to ensure collection and timely reporting of safety data. - Ensures that processes and systems are in [...]

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