Clinical Manager
- Recruiter
- Confidential
- Location
- Cambridge
- Salary
- Competitive
- Posted
- 10 Jun 2022
- Closes
- 08 Jul 2022
- Sectors
- Health, Nursing & Social Care, NHS
- Contract Type
- Permanent
- Hours
- Full Time
Here at SRG, we partner with an evolving and progressive biotech start-up in Cambridge. They are looking for a Clinical Manager to come and help develop and grow their clinical department. Reporting to the Director, Business development, Clinical and Regulatory, the primary purpose of this role is to work automatously, leading all aspects of management of the clinical studies.
As the Clinical Manager, you will be responsible for ensuring the clinical departments compliance with Good Clinical Practice (GCP), regulatory requirements and the company's Standard Operating Procedures (SOPs). Ensuring the clinical study administration is performed such that the subjects' rights, safety, and well-being are protected and that the clinical study data are reliable.
Some of your main duties and responsibilities will include:
Ensuring that the clinical project plan is up to date
Prepare, handle, distribute, file, and archive clinical documentation and reports
Owns the Study Master file and is responsible for accuracy and completeness
Prepare, handle and distribute Clinical Study Supplies and maintain tracking information.
Onboarding, training new or junior members of the team as needed
Supporting the implementation of new tools and systems to drive continual improvement and best practice for all the clinical studies.
Perform administrative tasks to support team members with clinical study conduct, as needed.
Document creation, management, retention and archiving, including but not limited to;
Review of essential documents e.g. Protocol, Monitoring Plan for compliance with clinical SOPs.
May assist in the preparation of essential documentation depending on experience.
Set up and maintenance of the Study Master Files (SMF) and Investigator Master File (IMF) and electronic filing systems, compliant to regulations and in audit ready state.
Site Management, support and logistics
Responsible for budget management. Collating, tracking & shipping of documentation. Managing monitoring visits scheduled between Clinical Research Associate, site and internal project team. Tracking and liaising with CRA and site to ensure actions are closed out. Instrumentation support and archiving.
Liaises directly with clinical sites to assist is issue and action resolution.
Clinical Study Database maintenance activities such as regular transfer of data files, format checking and collation. Furthermore, tracking tools set up and maintenance throughout the study.
Support CA function during audits e.g. Notified Body, BIMO, FDA, MHRA.
Liaises with the Clinical Study Manager (CSM) across projects.
As the ideal candidate, you will educate in a scientific or medical field with at least 3 years' experience in clinical trial planning and implementing for the medical technology industry. You will have experience in working with NHS sites and protocol submission through IRAS and be GCP certified. You will have working knowledge of ISO20916 and regulatory requirements for IVDs
As the Clinical Manager, you will be responsible for ensuring the clinical departments compliance with Good Clinical Practice (GCP), regulatory requirements and the company's Standard Operating Procedures (SOPs). Ensuring the clinical study administration is performed such that the subjects' rights, safety, and well-being are protected and that the clinical study data are reliable.
Some of your main duties and responsibilities will include:
Ensuring that the clinical project plan is up to date
Prepare, handle, distribute, file, and archive clinical documentation and reports
Owns the Study Master file and is responsible for accuracy and completeness
Prepare, handle and distribute Clinical Study Supplies and maintain tracking information.
Onboarding, training new or junior members of the team as needed
Supporting the implementation of new tools and systems to drive continual improvement and best practice for all the clinical studies.
Perform administrative tasks to support team members with clinical study conduct, as needed.
Document creation, management, retention and archiving, including but not limited to;
Review of essential documents e.g. Protocol, Monitoring Plan for compliance with clinical SOPs.
May assist in the preparation of essential documentation depending on experience.
Set up and maintenance of the Study Master Files (SMF) and Investigator Master File (IMF) and electronic filing systems, compliant to regulations and in audit ready state.
Site Management, support and logistics
Responsible for budget management. Collating, tracking & shipping of documentation. Managing monitoring visits scheduled between Clinical Research Associate, site and internal project team. Tracking and liaising with CRA and site to ensure actions are closed out. Instrumentation support and archiving.
Liaises directly with clinical sites to assist is issue and action resolution.
Clinical Study Database maintenance activities such as regular transfer of data files, format checking and collation. Furthermore, tracking tools set up and maintenance throughout the study.
Support CA function during audits e.g. Notified Body, BIMO, FDA, MHRA.
Liaises with the Clinical Study Manager (CSM) across projects.
As the ideal candidate, you will educate in a scientific or medical field with at least 3 years' experience in clinical trial planning and implementing for the medical technology industry. You will have experience in working with NHS sites and protocol submission through IRAS and be GCP certified. You will have working knowledge of ISO20916 and regulatory requirements for IVDs