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This is a excellent opportunity to join a growing pharmaceutical company that operates on an international level. You will be responsible for all operational clinical research activities of the clinical development programmes of compounds being developed within the CNS therapeutic area and responsible for the management of the clinical operational team.
KEY DUTIES AND RESPONSIBILITIES:
*Ensure that all studies are conducted in accordance with ICH/GCP guidelines, local regulatory requirements and company SOPs/WPs and in accordance with agreed timelines and budget.
*Liaise closely with other company personnel in regulatory, pharmacovigilance and technical services.
*Depending upon the stages of development the AD may need to liaise closely with company colleagues in Europe and around the world and contribute to global development issues.
*Depending upon the compound the AD may be required to liaise with co-marketing companies and the marketing groups within the company
*Ensure that cross departmental communication regarding clinical operation activities is adequate and facilitate any study teams with operational or communication difficulties.
*Line management responsibilities for the operational team within the Clinical Operations Group working on the programme and in association with the Director will assist in the development of these personnel.
*Manage all requests for support, data etc. from clinical operations in the US and other companies and will participate as requested in global meetings within the therapeutic area.
*Ensure quality of data from CNS studies are acceptable and suitable for regulatory submission.
*Manage research cost budgets for their projects and assist the Director in setting budgets and planning and allocating resource.
*To actively participate in company Group activities and recruitment and will support the Senior Director and Director, Clinical Operations in the improvement of departmental processes and participation in global projects.
*Use validated clinical trial management tools and systems to monitor overall programme timelines and will be expected to contribute to the improvement of processes used within the company for programme management.
*Prepare monthly reports of the work of their team for presentation to Director and will be expected to present status at corporate meetings.
*Actively gather information for review and distribution for their specific therapeutic area/compound in/with which he/she is responsible for.
ESSENTIAL QUALIFICATIONS AND EXPERIENCE:
*Science graduate BSc or above
PLUS
* Extensive clinical research experience to include relevant experience as a Clinical Project Manager of a European or Global Clinical Project.
* Possess a full understanding of current ICH/GCP guidelines
* Previous responsibility for the management of high calibre clinical trials design, execution and reporting
* Experience in CNS
* Confident decision maker
* Strong leadership skills
* ‘Hands on’ approach at all levels of clinical and non clinical work
* Flexibility
* Excellent interpersonal skills
Key Words: Associate Director Senior Project Manager Project Manager London London West London South Hertfordshire Middlesex Buckinghamshire Berkshire UK Anywhere CNS Central Nervous System
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