You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Essex, Kent, London - Central, London - North, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable (Up to 45000 £)
Apply by:
20 May 2008
This organisation is one of the Global Leaders in Biotechnology. With operations in over 30 counties and leading edge research there is huge potential for career development and growth. This is reflected in this organisations inclusion in ‘best 100’ employers rating as one of the best corporate employers in the UK. They are now recruiting for a Clinical Research Study Manager.
PURPOSE
To support the design and manage the operational activities related to the planning, implementation, and reporting of clinical trials in accordance with the global development plan and standard operating procedures.
Responsible for:
*The planning, management and reporting of clinical studies conducted by Development through oversight of cross-functional study activities; identification and resolution of issues; and communication of study timelines/deliverables
*Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
*Contributing to the Global Development Plan
*Contributing to/authoring study concept documents, protocols, clinical study reports, and publications
*Management of study budget, timelines and insourcing/outsourcing partners to the required standards
*May have line-management responsibilities of Clinical Trial Specialists Mentoring/training and career development of staff (where relevant)
KEY ACTIVITIES
*Coordinate the production, and contribute to the writing and review of study related documentation, including; Study Concept Document, Feasibility documentation, Protocol, Study Plans, Safety related documents, Clinical Study Report and publications
*Work with the Clinical Study Planner (CSP) to develop study timelines
*Evaluate the feasibility of the clinical strategy, including the design of feasibility assessments
*Contribute to the selection of clinical investigators
*Discuss study design with investigators/key opinion leaders and /or national accounts (where relevant)
*Participate in regional or global study teams and lead where relevant (Lead CRSM)
*Participate in the Global Clinical Studies Team
*Organise and where appropriate, lead Investigator, Study co-ordinator and CRA meetings
*Oversee the identification, selection, set-up, and management of CROs and vendors, including approval of invoices
*Develop and approve vendor scope of work/specifications
*Monitor completion of study data collection, analysis, and closure
*Identify and facilitate resolution of cross-functional study-specific issues
*Provide updates to Finance regarding the study budget and obtain approval for budget deviations for clinical sites (outside of range)
*Communicate study status to management and update relevant systems
*Contribute to the review and interpretation of study results
*Participate in cross-functional task forces/process improvement groups
QUALIFICATIONS
PhD, Pharm D., MPH, MS, or equivalent or BSc (Life Sciences) or BA/BS (Biological Sciences)
EXPERIENCE
*You will have strong European/Regional study management skills (global experience not essential).
*Working knowledge of International Conference on Harmonization (ICH) Good Clinical Practice (GCP), and applicable international regulations and guidelines
*Clinical Development process and procedures
*Project planning experience including oversight of study deliverables, budgets, and timelines
*Ability to use scientific and clinical knowledge to conceptualize study designs
*Experience anticipating and resolving problems
*Experience writing and presenting clearly on scientific and clinical issues
*Experience collaborating and leading cross-functional teams (team/matrix environment)
*Experience in oversight of outside vendors (e.g., CROs and contract labs) highly preferred
*Previous management experience preferred (for CRSM II)
Keywords: Clinical Research Study Manager Middlesex London Clinical Trials Project Manager CRO SCRA PM SM CRSM
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
.gif)
Site by Redder