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Clinical Manager (Epidemiology)
Eingestellt von Apex International
Gesuchte Skills: Design, Marketing
Projektbeschreibung
Job Title: Clinical Manager (Epidemiology)
Location: Buckinghamshire
Duration: ASAP - 6 months (Maternity Cover)
The Client: Global Pharmaceutical company
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the global study activities, the incumbent will work with the Regional Study Managers (RSM) to ensure correlation of global study activities.
Study concept, planning and strategy phase
The incumbent is responsible for: ensuring global study feasibility in collaboration with RSMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study timelines.
Study Initiation Phase
The incumbent is responsible for: global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrollment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan.
Study Management/Conduct Phase
The incumbent is responsible for: global IMP supply; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file oversight; ongoing management of protocol deviations; ongoing review of study data and data cleaning process.
Close-Out Phase
The incumbent will be responsible for: review of CSR shells; review of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; ensuring study documentation is properly archived when the study is considered completed
General
The incumbent may also act as the Program Operations Lead (POL) for a project.
The incumbent will be responsible for all regional study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the regional study activities in a global study, the incumbent will work with the GSML to ensure correlation of global study activities.
Study Concept, Planning and Strategy Phase
The incumbent is responsible for: ensuring regional study feasibility in collaboration with the GSM including summarizing regional assessment of patients and resource; initial assessment of vendors needed; and the development of regional specific study timelines.
Study Initiation Phase
The incumbent is responsible for: region-specific document development; assessing local vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of regional enrollment initiatives; input any regional specifics to the global study budget via the GSM; planning regional clinical study supplies.
Study Management/Conduct Phase
The incumbent is responsible for: regional investigator meetings/presentation of materials; regional financial management; database lock activities; regional study drug management; regional trial master file; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; ensuring compliance of serious adverse event reporting.
Close-Out Phase
The incumbent is responsible for: supporting database lock activities; ensuring all regional documents are filed in the CSR sections appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
Full details available on application
The Candidate:
Interpersonal Relationships
Communication Skills
Decision Making
Execution/Results/Process Improvement
Presentation Skills
Customer Satisfaction
Leadership (for people leaders only)
People and Talent Management (for people leaders only)
Science Degree with significant pharmaceutical industry or clinical development/medicine experience
Experience of site monitoring and study management responsibility is required.
Knowledge:
Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CRM is responsible.
Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies.
Approximately 25% travel is required in this role.
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
Keywords: Buckinghamshire, Clinical Manager (Epidemiology), Clinical Study Manager, Epidemiology, ICH-GCP, CRO
Location: Buckinghamshire
Duration: ASAP - 6 months (Maternity Cover)
The Client: Global Pharmaceutical company
Benefits: Competitive Salary and benefits available - Full details available on application
The Role:
The incumbent will be responsible for all study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the global study activities, the incumbent will work with the Regional Study Managers (RSM) to ensure correlation of global study activities.
Study concept, planning and strategy phase
The incumbent is responsible for: ensuring global study feasibility in collaboration with RSMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study timelines.
Study Initiation Phase
The incumbent is responsible for: global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrollment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan.
Study Management/Conduct Phase
The incumbent is responsible for: global IMP supply; study enrollment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file oversight; ongoing management of protocol deviations; ongoing review of study data and data cleaning process.
Close-Out Phase
The incumbent will be responsible for: review of CSR shells; review of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; ensuring study documentation is properly archived when the study is considered completed
General
The incumbent may also act as the Program Operations Lead (POL) for a project.
The incumbent will be responsible for all regional study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the regional study activities in a global study, the incumbent will work with the GSML to ensure correlation of global study activities.
Study Concept, Planning and Strategy Phase
The incumbent is responsible for: ensuring regional study feasibility in collaboration with the GSM including summarizing regional assessment of patients and resource; initial assessment of vendors needed; and the development of regional specific study timelines.
Study Initiation Phase
The incumbent is responsible for: region-specific document development; assessing local vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of regional enrollment initiatives; input any regional specifics to the global study budget via the GSM; planning regional clinical study supplies.
Study Management/Conduct Phase
The incumbent is responsible for: regional investigator meetings/presentation of materials; regional financial management; database lock activities; regional study drug management; regional trial master file; regional study enrollment management (e.g. contingency plan execution); ongoing review of protocol deviations; regional vendor management; ensuring compliance of serious adverse event reporting.
Close-Out Phase
The incumbent is responsible for: supporting database lock activities; ensuring all regional documents are filed in the CSR sections appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed.
Full details available on application
The Candidate:
Interpersonal Relationships
Communication Skills
Decision Making
Execution/Results/Process Improvement
Presentation Skills
Customer Satisfaction
Leadership (for people leaders only)
People and Talent Management (for people leaders only)
Science Degree with significant pharmaceutical industry or clinical development/medicine experience
Experience of site monitoring and study management responsibility is required.
Knowledge:
Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CRM is responsible.
Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research studies.
Approximately 25% travel is required in this role.
Application Details:
If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.
Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.
About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email
Apex International hold Investors in People status and are a corporate member of the Recruitment and Employment Confederation (REC).
Recommend a Friend Reward!!!! If you refer someone who is not currently registered with us and we find them a new position, Apex will repay you with a £200 voucher bonus (of your choice!)
Our Passion - Your Profession - A consultative approach to recruitment.
We match professional candidates to the best permanent, contract and interim roles in the market
Website:
Keywords: Buckinghamshire, Clinical Manager (Epidemiology), Clinical Study Manager, Epidemiology, ICH-GCP, CRO
Projektdetails
-
Einsatzort:
Buckinghamshire, Vereinigtes Königreich
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Medien/Design