Back to Job SearchWe are currently looking for a Clinical SOP Specialist to join a leading Pharmaceutical company in the Berkshire area. As the Clinical SOP Specialist you will be responsible for writing Standard Operating Procedures for including but not limited to Clinical site management, study plans, Study management, informed consents and clinical data management.
This is an initial 12 month contract with likely extension. This role can offer 3 days per week of remote working, with 2 days per week onsite.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical SOP Specialist will be varied however the key duties and responsibilities are as follows:
1. As the Clinical SOP Specialist you will support the development and maintenance of the quality management system and compliance infrastructure for global clinical sciences and operations. Create Standard Operating Procedures for including but not limited to Clinical site management, study plans, Study management, informed consents and clinical data management.
2. As the Clinical SOP Specialist you will partner with global quality, regulatory affairs, clinical strategic partners and other stakeholders to maintain compliance with Good Clinical Practice (GCP), International Council for Harmonisation guidelines and applicable local and international regulations. Provide guidance across clinical study phases, investigate complex compliance issues, and prioritise mitigation and escalation according to compliance and patient safety risks.
3. As the Clinical SOP Specialist you will understand clinical site management and ideally have clinical operations experience.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Clinical SOP Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree, alongside extensive pharmaceutical and clinical quality management experience. A background in clinical site management and clinical operations is particularly relevant.
2. Proven industry experience in writing standard operating procedures SOPs and experience of Good Clinical Practice (GCP).
3. A working knowledge and practical experience with Good Clinical Practice (GCP), international regulatory guidelines, quality systems and risk-based decision-making. Fluent spoken and written English, effective planning and project management, and strong presentation, training and influencing skills will support your work with colleagues, partners, vendors and senior leaders across a global environment.
Key Words: Clinical Quality / Process Quality Excellence / Good Clinical Practice / Quality Management Systems / Clinical Operations / Standard Operating Procedures / Corrective and Preventive Actions / Regulatory Intelligence / GCP / Clinical site management / study plans / Study management / informed consents / clinical data management.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
This is an initial 12 month contract with likely extension. This role can offer 3 days per week of remote working, with 2 days per week onsite.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical SOP Specialist will be varied however the key duties and responsibilities are as follows:
1. As the Clinical SOP Specialist you will support the development and maintenance of the quality management system and compliance infrastructure for global clinical sciences and operations. Create Standard Operating Procedures for including but not limited to Clinical site management, study plans, Study management, informed consents and clinical data management.
2. As the Clinical SOP Specialist you will partner with global quality, regulatory affairs, clinical strategic partners and other stakeholders to maintain compliance with Good Clinical Practice (GCP), International Council for Harmonisation guidelines and applicable local and international regulations. Provide guidance across clinical study phases, investigate complex compliance issues, and prioritise mitigation and escalation according to compliance and patient safety risks.
3. As the Clinical SOP Specialist you will understand clinical site management and ideally have clinical operations experience.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Clinical SOP Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree, alongside extensive pharmaceutical and clinical quality management experience. A background in clinical site management and clinical operations is particularly relevant.
2. Proven industry experience in writing standard operating procedures SOPs and experience of Good Clinical Practice (GCP).
3. A working knowledge and practical experience with Good Clinical Practice (GCP), international regulatory guidelines, quality systems and risk-based decision-making. Fluent spoken and written English, effective planning and project management, and strong presentation, training and influencing skills will support your work with colleagues, partners, vendors and senior leaders across a global environment.
Key Words: Clinical Quality / Process Quality Excellence / Good Clinical Practice / Quality Management Systems / Clinical Operations / Standard Operating Procedures / Corrective and Preventive Actions / Regulatory Intelligence / GCP / Clinical site management / study plans / Study management / informed consents / clinical data management.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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