Clinical Study Manager

Location
Oxford
Salary
Dependent on experience
Posted
12 Jun 2017
Closes
10 Jul 2017
Ref
J4007
Contact
Eve Hegarty
Contract Type
Permanent
Hours
Full Time
We are currently working exclusively with a new biotech firm based in the Central Oxford area. The company are a well funded biotech and have an exciting opportunity available for a Clinical Study Manager to join their growing team.

As the Clinical Study Manager you will be responsible for assisting with the clinical activities to support the company portfolio of vaccine based research and development projects.

The job is based in Central Oxford, but the company can offer working from home on occasion. We will expect all candidates to be able to move to the area, or be in a position to travel to site.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Clinical Study Manager will be varied however the key duties and responsibilities are as follows:

1. Management and oversight of all aspects of allocated studies in accordance with internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations. Oversight of all aspects of the study to ensure agreed study deliverables are met to the appropriate quality.

2. Responsibility for preparation of study documentation and coordination of document review, e.g. protocols, IBs, DSURs, ICFs, CSRs. Coordination of IRB/IEC and other required study submissions, and provision of essential documents to the Regulatory Head (or CRO if delegated) for regulatory submissions.

3. Selection and oversight of assigned CROs, vendors or contract monitors (CRAs). Selection of suitable clinical sites in collaboration with other members of the study team or CROs.

4. Set up and management of clinical contracts (including Clinical Site Agreements). Preparation of study budgets, forecasting and accruals.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Clinical Study Manager we are looking to identify the following on your profile and past history:

1. Relevant degree in a life science, pharmaceutical or related discipline. In addition to this, you will be expected to demonstrate clinical study management experience within a pharmaceutical, biotech or CRO business.

2. Proven industry experience in oversight of external vendors (CROs, central labs, imaging vendors, etc). Excellent working knowledge of GCP and current clinical trial legislation.

3. Thorough knowledge of the clinical development process, ideally from first in human through to regulatory filing for marketing.

Key Words: Clinical Study Manager | Clinical Trials | Pharmaceutical | Biotech | Vaccines | Vaccine Development | Vaccine Research | Clinical Research Organisation |

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.