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Mapi Group


Soort organisatie
Werkgever
Branche
Gezondheids/welzijn sector
Locaties
Leiden
Aantal medewerkers
1000+
Internationaal actief
Ja

Bedrijfsprofiel

Mapi is the industry’s only Company exclusively dedicated to Patient-Centered Real World research with over 40 continuous years of international operational experience.  Working within our Real World Evidence team you will work a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices.


Plan route

Afstand

Nieuwste vacatures

  • Clinical Research Associate, Late-Phase

    31-10-2017 00:00:00
    • 22 dagen geleden
    • 19 views
    • Leiden Leiden NL
    • 40 uur
    • WO/Universitair
    Summary: Mapi is the industry's only Company exclusively dedicated to Patient-Centered Real World research with over 40 continuous years of international operational experience. Working within our Real World Evidence team you will work a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. Your Responsibilities and Accountabilities: As a Late Phase Clinical Research Associate at Mapi Group, you will be responsible for performing all monitoring and site management activities for observational studies within the monitoring and site management (MSM) team. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements. Whilst some travel is required dependent upon your study, most of your work will be done on a remote basis with the primary focus being on the quality of data collected. Responsibilities: Perform site feasibility and site selection independently.Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiationsPerform site and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirementsContribute to and where necessary lead; sponsor or regulatory site audits/inspections including preparation, attendance and follow-up audit findingsMaintain regular site contacts to ensure site compliance, enrolment and understanding of study requirementsMaintain the Project Tracking System recording site visit dates, site contact notes, subject and site informationWrite and review project plans and templates Assist with the development of departmental and project specific processes and procedures You will have: A proven background as a CRA, ideally within late phase studies Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory) Proficiency with computer/software systems Proven ability to project manage multiple simultaneous tasks For non-native English speakers; possess strong written and verbal English skills Education Requirements: A degree preferably in a scientific, medical or life sciences discipline Mapi Making A Positive Impact Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. We are committed to improving the quality of patient care worldwide by offering innovative and insightful solutions for successful market access to people who are shaping tomorrow's health care whilst always ensuring the voice of the patient remains at the heart of what we do. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post- marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers. Our Values: At Mapi, we embrace our values, and everyone that works here is expected to demonstrate these values and associated behaviours in their day-to-day work. Our values are the foundation of the work we do and include Integrity, Efficiency, Taking an Interest in others and having a Pioneering spirit. We provide a dynamic and rewarding working environment for passionate individuals looking to join a world-class consultancy business. Our management team looks to coach, develop, encourage team spirit and share best practices via open and honest communication whilst at the same time ensuring that you still maintain a great balance between your professional and personal life.
  • Clinical Research Associate Late Phase

    31-10-2017 00:00:00
    • 22 dagen geleden
    • 20 views
    • Leiden Leiden NL
    • 40 uur
    • WO/Universitair
    Summary: Mapi is the industry's only Company exclusively dedicated to Patient-Centered Real World research with over 40 continuous years of international operational experience. Working within our Real World Evidence team you will work a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. Your Responsibilities and Accountabilities: As a Late Phase Clinical Research Associate at Mapi Group, you will be responsible for performing all monitoring and site management activities for observational studies within the monitoring and site management (MSM) team. You will perform routine site visits to ensure that the rights and well-being of human subjects are protected; the trial data is accurate, complete, and verifiable from source documents. You will ensure that all activity is delivered in accordance with the study protocol, GCP/ICH/GEP guidelines and applicable regulatory requirements. Whilst some travel is required dependent upon your study, most of your work will be done on a remote basis with the primary focus being on the quality of data collected. Responsibilities: Perform site feasibility and site selection independently.Work closely with relevant departments to performRegulatory and IEC/IRB submissions and contract negotiationsPerform site and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirementsContribute to and where necessary lead; sponsor or regulatory site audits/inspections including preparation, attendance and follow-up audit findingsMaintain regular site contacts to ensure site compliance, enrolment and understanding of study requirementsMaintain the Project Tracking System recording site visit dates, site contact notes, subject and site informationWrite and review project plans and templates Assist with the development of departmental and project specific processes and procedures You will have: A proven background as a CRA, ideally within late phase studies Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory) Proficiency with computer/software systems Proven ability to project manage multiple simultaneous tasks For non-native English speakers; possess strong written and verbal English skills Education Requirements: A degree preferably in a scientific, medical or life sciences discipline Mapi Making A Positive Impact Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. We are committed to improving the quality of patient care worldwide by offering innovative and insightful solutions for successful market access to people who are shaping tomorrow's health care whilst always ensuring the voice of the patient remains at the heart of what we do. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post- marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers. Our Values: At Mapi, we embrace our values, and everyone that works here is expected to demonstrate these values and associated behaviours in their day-to-day work. Our values are the foundation of the work we do and include Integrity, Efficiency, Taking an Interest in others and having a Pioneering spirit. We provide a dynamic and rewarding working environment for passionate individuals looking to join a world-class consultancy business. Our management team looks to coach, develop, encourage team spirit and share best practices via open and honest communication whilst at the same time ensuring that you still maintain a great balance between your professional and personal life.

Contactgegevens
Mapi Group
Bargelaan 200
2333CW Leiden
Bargelaan 200 Leiden, NL
Bedrijfswebsite

Contactpersoon
M Spierenburg