Job title: Operations Manager - Statistics & Programming
Salary: Dependent on experience
Position type: Permanent
Location: South East
Job summary:
This is an extraordinary opportunity to be part of a new outsourcing
business model that will be the only one of its kind in the UK. You will
play a key role in setting up two new offices in the South East of England
serving the biometric (i.e. CRF Design, Coding Dictionaries, Data
Management, Statistics & Programming of phases 1 to 4 clinical trials)
outsourced needs of a global pharmaceutical company.
We are seeking a high calibre, experienced Operations Manager ideally
skilled in the field of clinical trial statistics and programming who will
manage the overall biometric functional needs of one or both sites dependent
on experience and expertise. Supported by senior management and reporting
into the Operations Director, this role will provide you with the
opportunity to have a major input into the development of a new business
model from inception through to optimising the business processes to achieve
project deliverables.
Role and responsibilities:
Ideally we are looking for an experienced individual who not only has the
functional area expertise but who will play a key role during set up phase.
This includes input into the HR Planning, Office logistics and set-up,
financial and legal support, process development and QA as well as IT and
Health and Safety.
At steady-state you will be responsible for the resource and management of
30-40 biometrics staff to include data management, CRF design, dictionary
coding, statistics and programming. Together with the Operations Director
you will ensure project delivery to agreed timelines, within budget and to a
high quality standard. This will involve quality control of all client
deliverables including SOP adherence, therefore knowledge of regulatory
requirements is crucial.
Input will be required into contract management and you will be responsible
for negotiating budgets and managing scope as well as liaison with the
client and 3rd party suppliers.
Overall you will be accountable for the leadership and motivation of your
teams. Together with three direct reports (Team Leaders) you will be
managing the resource of the site, outlining training plans (to include
technical and non-technical training), appraisals and overall development of
staff based on performance. You will need to be competent in managing teams
upwards and downwards to ensure absolute delivery to the client.
Qualifications and experience:
* MSc (or equivalent) in Medical statistics
* 10 years + experience in statistics & programming of
clinical trials in a CRO or pharmaceutical environment
* Good understanding of data management, CRF design, coding,
statistics and programming
* Significant relevant management experience
* Experienced in client liaison
* Experience in budget control and financial management
* Experience of office set-up activities an advantage
* Knowledge of relevant regulatory requirements i.e. FDA and
ICH/GCP guidelines.
Personal attributes:
* Excellent Leadership skills
* Ability to prioritise and manage multiple tasks
* Excellent organisational and analytical skills
* Excellent inter-personal and team work ability
* Excellent communication and presentation skills
* Excellent knowledge of spoken and written English
* Ability to negotiate and influence others across multiple
functional areas
To apply for this role or find out about related opportunities please
contact Jonathan Hart-Smith on 0870 0605268, email at
[log in to unmask] or visit our website at www.ircl.co.uk
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