Clinical Study Manager, Stem Cell Biology. Phase II/ III Trials

Job Category:
Pharmaceuticals / Biotechnology / Forensics / Medical Devices
Job Type:
Permanent
Region:
South Wales
Town:
South Wales
Salary Description:
Attractive, negotiable salary + Benefits
Posted:
27/04/2017
Recruiter:
SCI Recruitment for Scientists
Job Ref:
19489

Clinical Study Manager, Stem Cell Biology. Phase II/III Trials

Job Ref: 19489


This is an exciting opportunity to work within a fast paced, busy environment in a leading, clinical-stage stem cell biotechnology business whose primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need. Having successfully completed its early phase clinical trials, the Company is now looking to embark upon its Phase II/III programs and is seeking a highly talented and motivated individual to implement and lead these global studies. 


Our Clinical Study Managers act as the functional lead from Clinical Operations with responsibility for delivery of all Clinical Operations aspects of clinical studies ensuring consistency with Company SOPs/Procedures, study contracts, budgets and timelines.


Key Responsibilities

- Responsible for planning, scheduling and implementing all functional activities, and the overall coordination and management of Phase II-III clinical trials from start up through to clinical study report 

- Responsible for primary interactions with internal and external cross-functional teams and key stakeholders, and ensuring study objectives are met

- Development of clinical project plans, study budgets and timelines, and communicates project status and issues 

- Tracks Clinical Operations project deliverables using appropriate tools 

- Responsible for development of RFPs, the assessment and selection of CROs/vendors 

- Oversees the day-to-day activities of CROs/vendors (across all functions) by serving as primary contact point, addressing questions and resolving issues

- Responsible for writing, and coordinating the review of key study documents, including protocols, informed consents, case report forms, monitoring plans and clinical study reports

- Coordinates all regulatory and REC/IRB associated activities 

- Coordination of audits and preparing and responding to CAPAs

- Updating SOPs and review of clinical operations processes

- Responsible for risk mitigation strategies, associated action plan and issue resolution


Key Requirements

- Minimum of a bachelor’s degree in life science, medical or related field

- 1-3+ years of clinical research experience gained with a CRO or Pharmaceutical Company working on Phase I to III pharmaceutical clinical studies 

- Additionally, 3+ years clinical project management experience of managing studies outsourced to a CRO

- Strong scientific background and prior experience in cardiovascular (stroke), ophthalmology or oncology therapeutic areas is desirable

- Experience of working with GMOs is desirable

- Comfortable working independently and within very small teams

- Thorough knowledge and understanding of ICH GCP, FDA CRF 21 and EMEA regulations and guidelines for the conduct of clinical trials

- International travel: up to 25%

- Fluent in written and spoken English

- Clean current driving licence


Role: Permanent 

Location: South Wales

Salary: Attractive, negotiable salary + Benefits


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Contact Details:
SCI Recruitment for Scientists
Tel: 01606 818290
Contact: Andy Cuthbert
Email:

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