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Job Details

Clinical Study Manager

Company: Hobson Prior
Location: Surrey
Reference: HR444187
Closing Date: 14 Mar 17
Type: Permanent
Salary (£): On Application
Benefits: 60000

Job Summary:

· 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

Requirements:

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

·         Conducts Monitoring/co-monitoring as required

Provides support and training for other staff members on specific areas of expertise
·         Prepares and presents at Investigator Meetings and other external conferences

·         Contributes to Clinical Operations team activities & initiatives

 

Minimum Qualifications and 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 (including satisfactory progression of monitoring experience)

·         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

·         Natural gravitas and strong communication skills

·         Demonstrated ability to prioritise, juggle multiple competing tasks and demands, and work under pressure

·         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%

·         Strong working knowledge of MS Word, Excel, Power Point and Outlook

·         Fluent in written and spoken English

·         Clean current driving licence

 

 

 

 

 

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
kent
TN1 1HT
England
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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