Job Title: Clinical Research Manager CRM London Based
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London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable (Up to 53000 $)
Apply by:
29 Jan 2009
An exciting opportunity based in London for an experienced Clinical Research Manager with Phase I experience to lead designated clinical development programmes and the associated clinical trials within those programmes for which the company has responsibility. - To ensure the clinical trials within the designated clinical programmes are conducted to the agreed schedule and budget in collaboration with the Clinical Project Managers.
In collaboration with senior members of staff to lead clinical programmes including the research, design and authoring of full clinical development plans for a designated compounds and to be capable of understanding and analysing competitor clinical dossiers (e.g. Summary Basis of Approval and European Public Assessment Reports) sufficiently to produce extracted information and analysis to support activities of senior members of staff.
Maintains basic awareness of current and developing clinical profiles of both developmental and marketed competitor products.
To have a working knowledge of toxicology and non-clinical pharmacology as they relate to clinical development and pharmacokinetic principles and applicability to drug development.
To acquire and maintain in depth knowledge of designated Investigational Medicinal Products (IMPs) and related therapy area knowledge. To act as training resource of detailed IMP and related therapy area knowledge within the company on designated clinical programmes.
If requested by the HCR to line manage or act as a mentor/supervisor for assigned staff working in the clinical development department.
For clinical trials within the designated programmes to review and provide clinical input to analysis plans (e.g. including but not limited to Statistical and Pharmacokinetic analysis plans) and other documents essential to the integrity of the clinical trial and clinical trial data.
To have an overview of the clinical studies for the assigned products and to assist the CPMs in all aspects of running the clinical trials including (but not limited to): trial specific timelines, clinical site selection, vendor selection and management, trial set up, budgeting, timeline reporting,
and trial close-out activities.
To be involved in contingency planning and implementation thereof across assigned clinical development plans and clinical trials including vendor management.
To conduct KOL/consultant visits and manage KOL/consultant relationships that supports effective clinical development. To maintain knowledge and demonstrate interpersonal skills that enables interaction with KOLs to be scientifically and professionally credible.
When selecting KOLs or general consultants to be familiar with information sources, capable of making sound judgements on the suitability of potential candidates and capable of understanding the company’s requirements from such KOLs or consultants
To be the primary author of clinical trial synopses. To lead, present and focus discussion of proposed clinical trial synopses both internally (e.g. between the company, and externally with relevant KOLs and/or prospective investigators. To author/review, provide input and approve full clinical protocols.
To be able to develop presentation material and/or present at Scientific Advisory Board meetings.
To be able to develop presentation material and/or present at Regulatory Authority meetings.
To attend external medical and scientific meetings and to communicate key messages to the programme team(s).
To author posters and papers and as required present at scientific and medical meetings.
To author or review clinical sections of the CTA or IND (e.g. items 9 and 4) or review other CTA/IND sections from a clinical science perspective ensuring coherence and alignment with the overall clinical research goals for that product. As required, to co-ordinate the review process of the CTA/IND within the company and to have input where appropriate to the content of the CTA/IND.
To author or review clinical sections of the IB from a clinical research perspective ensuring coherence and alignment with the overall clinical development goals for that product. As required, to co-ordinate the overall review process of the IB within the company.
For designated clinical trials to provide an ongoing review of safety data (Serious) Adverse Events, laboratory data and any other trial specific data) relevant to the conduct of such a review.
To author company SOPs and guidelines as required.
To lead the training of staff in applicable content of company SOPs for which the post holder has responsibility as trainer.
To provide input where appropriate for product licensing (‘MAA/NDA’) activities.
Participates in internal discussion and implementation of new approaches in clinical development.
To carry out such other tasks as are assigned from time to time by the HCR, SCRM, or Managing Director. Annual objectives will be set and performance review and the establishment of training needs will be undertaken according to Company policies
Keywords: Clinical Research Manager Senior Clinical Manager Senior Project Manager London
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