Clinical Process Manager Stellenangebote


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223 Stellenangebote


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Job vor 10 Tagen gefunden Takeda GmbH

Process Validation Engineer (f/m/d)

• Singen
MEHRBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda [...] with other VBU functions for example CMC, External Manufacturing, PO, Quality and External Partners CMOs to generate and execute process and product technology transfers and the associated qualification and validation activities In this position you will report to the Senior Manager, Vaccines MS T Validation. What you bring to Takeda: You have completed studies in the natural sciences field Several years of experience in lifecycle process validation in manufacturing operations onsite and with CMOs for commercial and clinical manufacturing Extended knowledge in Process Performance Qualification, Continued Process Verification, and risk management Practical experience in vaccine production Expertise in [...]
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Stellenangebot Clinical Process Manager Job bei Bruker Physik GmbH 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 [...] implementation project lifecycle including documentation Consult the global Business community in Materials Management/ Stockroom Manamgement and Quality Management. Drive the Business organization in the definition and the creation of Business Requirements, be accountable for the creation of Solution Proposals Design process solutions, create functional specification documents and act as broker between the Business and the Global IT organization Align new solutions [...] 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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Job vom 13.10.2024

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

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen
MEHRDrug 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 [...] adequate title) in Chemistry or Pharmaceutical technology or other adequate title. More than 3 years of professional experience in pharmaceutical/ Biotech industry. Expertise in galenic development for solid and liquid forms including i. v. formulations. Advanced knowledge of Drug Development process, analytical development and validation as well as GMP/ CMC and regulatory requirements. Ability to efficiently evaluate, prioritize and handle multiple [...]
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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 [...] 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 [...] entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate [...]
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Job vom 18.09.2024

Site Care Partner I- (, , Remote)

MEHR[...] reviewed and updated when major staffing, contracting, or other significant site changes/ issues occur to confirm that continuity and contingency plans are current. Review and manage site practices that differ from client practices and liaise with study management and Business Process Owners as needed. Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study- [...] 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 [...] reviewed and updated when major staffing, contracting, or other significant site changes/ issues occur to confirm that continuity and contingency plans are current. Review and manage site practices that differ from client practices and liaise with study management and Business Process Owners as needed. Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study- [...] 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 30.08.2024

Chief Operating Officer (Managing Partner; f/m/d)

• Berlin Führungs-/ Leitungspositionen
MEHR[...] applications or to explore alternative financing options at the outset, with a view to facilitating the implementation of the study. The final stage is the autonomous execution of day- to- day operations. Subsequently, following the completion of the primary research process, the main focus will shift to production and logistics, with a view to implementing continuous improvement measures. Consequently, the selection, [...] must be driven by intrinsic willpower and sustained through own determination) . Was wir Ihnen bieten A network of mentors has been created to enhance the management competencies of the organization: Prof. Dr. Meike Watzlawik, head of master program in clinical psychology, scientist, organizational developer, and career consultant; Christian Walker, microbiologist, MBA, consultant for science start- ups, and CEO of a [...] : Ass.- Prof. Dr. Jan Aden, psychologist, scientist, head of an institute for statistics; Chemical methodology : Dr. Johannes Fischer, chemist, PhD in nutritional sciences, researcher of neurodegenerative diseases, former business consultant; Diagnostic methodology : Nicole Langer, psychologist, coach, project manager, lecturer for diagnostics and psychometrics. In addition to professional guidance, as a managing partner in business development, one will endeavor [...]
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Job vom 01.08.2024 Site Care Partner- FSP- (, , Remote)
MEHR[...] reviewed and updated when major staffing, contracting, or other significant site changes/ issues occur to confirm that continuity and contingency plans are current. Review and manage site practices that differ from Client practices and liaise with study management and Business Process Owners as needed. Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study- [...] 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 [...]
Job vom 19.06.2024

Neurology Medical Director (Associate/ Senior)

Führungs-/ Leitungspositionen
MEHR[...] and health. We push science forward by conducting groundbreaking research, developing ground- breaking treatments, and supplying our teams with the tools necessary to help each member of the team realize their professional ambitions. Our work encompasses laboratory, digital, and decentralized clinical trial services, with clinical trials carried out in more than 100 countries and the continuous development of innovative frameworks for [...] our PPD clinical research portfolio. People and communities that rely on improved health outcomes today and in the future will benefit from your commitment to providing quality and accuracy. Discover impactful work: Throughout all stages of the clinical drug development process, this role offers tactical oversight and strategic leadership for the clinical and medical components. In compliance with relevant GCP standards, [...] such as not being able to access the career website, getting in touch with someone about an application, or other technical problems unrelated to a disability, wont be answered. Job Title: Stem Cell Laboratory Technologist Job Title: Assistant Digital Marketing Manager Job Title: Outlet Manager- Mekong Restaurant Job Title: Medical translator/ proof reader Job Title: Post doctor in Medical Radiation Sciences [...]
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Jobbörse Stellenangebote Clinical Process Manager Jobs gefunden bei Jobbörse StepStone

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Stellenangebot Clinical Process Manager Job bei Immatics Biotechnologies GmbH Neu Job vor 7 Std. gefunden Immatics Biotechnologies GmbH Senior Manager Clinical Quality Assurance (m/w/d) • bundesweit Homeoffice möglich Jobticket
MEHRImmatics 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 [...] e. g. , QMS SOPs, working instructions, and respective quality documentation related to clinical trial management activities CQA Quality Management counterpart for the operational clinical functions; provision of guidance and support to clinical functions for e. g. , protocol and process deviation management, change controls, root cause analyses, CAPA definitions for deviations/ audits and inspection observations, vendor selection and oversight aspects [...]
Stellenangebot Clinical Process Manager Job bei Edwards Lifesciences Services GmbH Job vor 8 Tagen gefunden Edwards Lifesciences Services GmbH

Therapy Activation Specialist TMTT- EVOQUE (device specialist; Germany- north/ north- east)

• Schleswig- Holstein, Mecklenburg- Vorpommern, Berlin, Brandenburg, Niedersachsen, Sachsen- Anhalt Homeoffice möglich
MEHR[...] Physicians) within the field. To accelerate new account certification and learning curve in support of site opening and physician training will be your key duty. Providing feedback to PEMA leadership commitment competence of HCP s and support procedures as a Clinical Specialist will be very important part of your job. You will be playing pioneering role assuring best experience with EVOQUE, the first tricuspid valve, and future TMTT therapies eliminating open heart surgery You will be an expert on our EVOQUE therapy/ device We are strengthening our Professional Education Medical Affairs European team (PEMA) This role is reporting to Manager, Therapy Activation, TMTT- EVOQUE, PEMA Apply in English Your core duties: Lead the Site Opening Process, working closely with local internal stakeholders and the customer in their territory. Assess HCP competencies throughout the site opening process [...]
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Job gestern gefunden PR Innovation GmbH Project Manager (m/f/d) for clinical trials focussing on neurodegenerative deseases • Düsseldorf Homeoffice möglich
MEHRPR Innovation GmbH sucht in Düsseldorf eine/n Project Manager (m/f/d) for clinical trials focussing on neurodegenerative deseases (ID- Nummer: 11718089) . We, PR Innovation GmbH, are a foundation of the Federal Agency [...] and external partners to clarify specific project requirements. Assist senior managers in delegating project tasks to junior team members based on members individual strengths, skill, and experience levels. Review comprehensive project plans. Assist in audits and inspections. Develop tables, diagrams, process flows, and training materials as needed. Perform other related duties as assigned. Requirements: Must be a strong team player with [...]
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Job vor 4 Tagen gefunden Conn Cons GmbH

Product Manager/in (m/w/d) Software

• Dresden Homeoffice möglich Jobticket
MEHRConn Cons GmbH sucht in Dresden eine/n Product Manager/in (m/w/d) Software (ID- Nummer: 11710120) . Connected Consumables is a growing startup dedicated to revolutionizing the safety and availability of [...] oversee the entire product lifecycle from strategy to development and successful launch bridging the gap between doctors, nurses, pharmacists, and logistics to improve cancer treatment workflows. You will act as the key link between our development team and stakeholders, including clinical staff and technical service providers. Leveraging your deep understanding of medical workflows, you will define the product vision, prioritize features, [...] and offers room for creativity. This includes hybrid working arrangements. Interdisciplinary Team : Our development team brings together experts from various technologies as well as full- time clinical staff, including nurses, doctors, and pharmacists, who are integral to the development process. Team Spirit : Look forward to working in a motivated and collaborative team that values enthusiasm, mutual support, and a [...]
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Stellenangebot Clinical Process Manager Job bei Daiichi Sankyo Europe GmbH 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
MEHRDaiichi 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 [...] clinical trial related matters working with authorities, affiliates, partners and CROs. Act as a regulatory contact person for European clinical trial matters within Daiichi Sankyo RA Support with advice and provide clear information to clinical study teams on administrative and process related aspects of clinical trial submissions in Europe (EU, UK, CH) Act as a coordinator of responses to agency questions [...]
Job vom 05.11.2024 bess AG

Clinical Affairs Manager (m/w/d)

• Berlin Teilzeit
MEHRbess 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 [...] clinical evaluations and periodic safety update reports for medical devices (in English) Conduct literature searches and evaluations Support the planning and coordination of preclinical and clinical studies for device approval and Post- Market Surveillance Provide support to the risk management process by contributing to risk analyses and the evaluation of residual risks Work in close collaboration with R D, Product Management [...]
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Stellenangebot Clinical Process Manager Job bei Dr. Falk Pharma GmbH Job vom 05.11.2024 Dr. Falk Pharma GmbH Global Medical Science Manager (m/w/d) • Freiburg Homeoffice möglich
MEHRDr. Falk Pharma GmbH sucht in Freiburg eine/n Global Medical Science Manager (m/w/d) (ID- Nummer: 11678742) . As the experts in digestive and metabolic medicine and as a family- owned business with [...] that medical progress can only be achieved by working together. That is why we are looking for: We look for someone who is a healthcare enthusiast and who is capable of assimilating and interpreting scientific content or a wealth of clinical efficacy and safety data with adeptness in ability to translate into a logical, scientifically balanced compelling medical story for appropriate [...] investigator brochures clinical parts) - with focus on epidemiology, therapeutic area or indication background, national and international guidelines and patient journey/ medical need, based on study reports, medical- scientific publications and other literature and key external experts insights Answer and process (in close cooperation with the global safety department) internal and external medical inquiries from health care providers, patients, affiliates colleagues [...]
Job vom 03.11.2024 Eurofins Genomics Europe Shared Services GmbH

Transformation Manager Order- 2- Cash Europe (jun./ sen. ) (m/f/d)

• Ebersberg
MEHREurofins Genomics Europe Shared Services GmbH sucht in Ebersberg eine/n Transformation Manager Order- 2- Cash Europe (jun./ sen. ) (m/f/d) (ID- Nummer: 11660368) . Eurofins Genomics is globally known for its innovative [...] pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 62, 000 staff [...] EUR 6. 515 billion, and has been among the best performing stocks in Europe over the past 20 years. Establishment of lean sustainable End- 2- End Order- 2- Cash Processes across Europe Manage compliance with Eurofins internal requirements and ensure process standardization harmonization within Genomics Europe Manage pan- European Invoicing Processing Team of highly motivated professionals Create Center of expertise for [...]
Stellenangebot Clinical Process Manager Job bei Bruker Physik GmbH Job vom 02.11.2024 Bruker Physik GmbH SAP Inhouse Consultant Mm/wM/ QM (m/f/d) • Porto, Ettlingen Beratungs-/ Consultingtätigkeiten
MEHR[...] 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 [...] implementation project lifecycle including documentation Consult the global Business community in Materials Management/ Stockroom Manamgement and Quality Management. Drive the Business organization in the definition and the creation of Business Requirements, be accountable for the creation of Solution Proposals Design process solutions, create functional specification documents and act as broker between the Business and the Global IT organization Align new solutions [...]
Stellenangebot Clinical Process Manager Job bei ZEISS Job vom 21.09.2024 ZEISS

Quality Manager Specialist (f/m/x)

• München
MEHRZEISS 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 [...] medical devices or medical software- only products, as advisor and supporter of the project manager and the project team Analyze and review the product documentation, as well as approve and contributing product- specific and quality- oriented feedback, thereby ensuring the process- compliant development of the software Support and coordinate risk management activities according to ISO 14971 together with interdisciplinary teams Check [...] 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 [...]
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