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Principal Study Management Associate (Dermatology)
Eingestellt von Apex International
Gesuchte Skills: Client, Marketing
Projektbeschreibung
Job Title: Principal Study Management Associate (Dermatology)
Location: Buckinghamshire
Duration: Minimum 12 month contract to start ASAP
The Client: Global pharmaceutical company
Benefits: Competitive daily rate payable - Full details available on application
The Role:
The employee is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies. The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Client departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Client policies, and procedures. Client policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
Full details available on application
The Candidate:
Qualifications / Experience
B.A./B.Sc. preferably in science or health-related field
Previous experience of clinical study management
Oversight or mentoring of more junior study monitors (direct or indirect) preferred
Dermatology experince benefical but NOT essential.
Phase III global study management experince IS essential
Knowledge and Skills
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development
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:
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Location: Buckinghamshire
Duration: Minimum 12 month contract to start ASAP
The Client: Global pharmaceutical company
Benefits: Competitive daily rate payable - Full details available on application
The Role:
The employee is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies. The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Client departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations. The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications.
The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization. Other activities, special projects and assignments may be given as required. As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.
The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all Client policies, and procedures. Client policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives
Full details available on application
The Candidate:
Qualifications / Experience
B.A./B.Sc. preferably in science or health-related field
Previous experience of clinical study management
Oversight or mentoring of more junior study monitors (direct or indirect) preferred
Dermatology experince benefical but NOT essential.
Phase III global study management experince IS essential
Knowledge and Skills
Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
Knowledge of concepts of clinical research and drug development
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:
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Projektdetails
-
Einsatzort:
Buckinghamshire, Vereinigtes Königreich
-
Projektbeginn:
asap
-
Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Marketing/Vertrieb