Job Title: ASSOCIATE DIRECTOR / SENIOR PROJECT MANAGER - INTERNAL MEDICINE
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Vacancy details
Vacancy description:
Job Code:
J759691
Job Title:
ASSOCIATE DIRECTOR / SENIOR PROJECT MANAGER - INTERNAL MEDICINE
London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
ASSOCIATE DIRECTOR / SENIOR PROJECT MANAGER - INTERNAL MEDICINE
An excellent opportunity to work with a top global Pharmaceutical company who are currently developing a number of diverse and exciting products. Working within this large company will be an fantastic opportunity to broaden your experience, and, with no Director for Internal Medicine at the current time the long term prospects for this position are extremely promising with respect to promotion, enabling you to take your next step up the career ladder!
ROLE:
In this role you will be reporting into the Head of Clinical Operations and the International Project Team Leader, heading the Internal Medicine function. You will be responsible for all operational clinical research activities of the clinical development programmes of compounds within the frontier research / internal medicines therapeutic area, which includes cardiovascular and anti-infective compounds. You will be responsible for the management of the clinical operational team working within the Clinical Operations Group.
KEY DUTIES AND RESPONSIBILITES:
* Ensure that all studies are conducted in accordance with ICH/GCP guidelines, local regulatory requirements and SOPs/WPs and in accordance with timelines and budget.
* Liaise closely with personnel in Regulatory, Pharmacovigilance and Technical services.
* Ensure that cross-departmental communication regarding clinical operations activities is adequate and facilitate any study teams with operational or communication difficulties.
* Line manage the operational team within the Clinical Operations Group and, in association with the Director, assist in the development of these personnel.
* Manage all requests for support, data from international sections of the company
* Participate as requested in global meetings within the therapeutic area.
* Ensure quality of data from frontier research/internal medicines studies is acceptable and suitable for regulatory submission.
* Manage research cost budgets for their projects and assist the Director in setting budgets and planning and allocating resources.
* Actively participate in recruitment, and 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 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 the Director and present status reports at corporate meetings.
* Actively gather information for review and distribution for their specific therapeutic area/compound in/with which he/she is responsible for.
ADDITIONAL RESPONSIBILITES:
* You may need to liaise closely with colleagues internationally and contribute to global development issues.
* You may be required to liaise with co-marketing companies and the marketing groups within the company.
ESSENTIAL SKILLS AND QUALIFICATIONS:
* Science graduate - preferably MSc or PhD
* Extensive clinical research experience as a Clinical Project Manager of a European or Global Clinical Project
* Experience in cardiovascular required.
* Possess a full understanding of current ICH/GCP guidelines
DESIRED ATTRIBUTES:
- Broader experience in different therapeutic areas is highly desirable – e.g. anti-infectives and other FR/IM areas
- Confident decision maker with strong leadership skills
- ‘Hands on’ approach at all levels of clinical and non clinical work
- Flexibility
- Excellent interpersonal, reporting and communication skills
Key Words: Internal Medicine IM Cardiovascular CVS Anti-Infectives Associate Director Senior Project Manager PM SPM Hertfordshire Middlesex Bedfordshire Essex Berkshire UK Anywhere South South East clinical operations manager
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