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Senior Clinical Study Manager

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Cpl Life Sciences

2021-12-03 13:51:51

Job location Cambridge, Cambridgeshire, United Kingdom

Job type: fulltime

Job industry: Science & Technology

Job description

*Senior Clinical Study Manager*
Permanent
UK Elstree Hybrid 1x a week in office.
Salary: circa 65,000 plus benefits
We have a new opening for an experienced Senior Clinical Study Manager to join a small pharma company. This is an exciting business that deliver life-saving treatments for conditions related to autoimmune deficiencies, bleeding disorders and critical care. You will initially be responsible for study management of one Phase I US based study with key responsibilities around vendor set up and oversight and key document preparation.
*Key Responsibilities:*
-CRO and Vendor management
-Feasibility and site selection
-Delivery of clinical trial through the full life cycle
-Budget management
-Risk management strategies, quality assurance and audits
-Investigational Medicinal Product (IMP) and Supplies Management
-Prepare/review clinical trial protocols, subject information leaflets/consent forms and Investigator Brochures.
-Mentor clinical research staff and consultants, including the induction and training for new/junior team members.
*Key Requirements:*
-Minimum 6 years of CSM experience
-Phase I and start up experience
-Strong scientific and/or operational experience
-Vendor management experience, especially with CROs.
-Experience reviewing/preparing key clinical trial documentations protocols, investigator brochures, SOPs, Consent forms.
-Flexible attitude
-Pharma and/or CRO experience
If this role is of interest, please send your CV to [ ](mailto:)or call for more information.

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