Job title: Operations Director, Statistics
Salary: Excellent Salary and benefits
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 be
responsible for 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 clinical trials across phases 1 to
4) outsourced needs of a global pharmaceutical company.
We are seeking an experienced Operations Director to play a pivotal role in
the development and continual success of this business. Supported by senior
management 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:
You will be responsible for co-ordinating the set-up and management of the
new office facilities to ICH-GCP standards. This includes the overall
management of Human Resource planning, office logistics and set-up,
financial and legal support, process development and QA as well as IT and
Health and Safety.
The Operations Director has overall responsibility for managing budgets,
hiring of new staff, staff training and development plans, line management
and co-ordinating all resource requirements across the functional areas of
data management, statistics and programming, CRF design and dictionary
coding.
Through the start up phase, the role holder will be required to manage the
recruitment of employees as well as oversee the preparation of HR materials
such as Staff Handbook, contracts, and training etc.
During steady state you will ensure that projects receive adequate resources
and that they are delivered on time, to budget and to the highest quality
standard.
You will have overall accountability for financial and performance targets
to include negotiating budgets and managing scope as well as negotiating
contracts with 3rd party suppliers.
This is a client facing, customer focussed role therefore ideally we are
looking for a dynamic and free-thinking individual with excellent
communication skills and the ability to make decisions to lead a team of
80-90 staff successfully. Overall the Operational Director's role is to
ensure delivery whilst minimising project risk.
Qualifications and experience:
* Life Science/Computer Science degree or equivalent
qualification
* 12 years + experience in biometrics functions in a CRO or
pharmaceutical environment
* Detailed knowledge and experience of data management, CRF
design, coding, statistics and programming
* Significant relevant management experience
* Experience of client liaison
* Experience in budget control and financial management
* Demonstrated abilities in project management, strategic
thinking and relationship management
* Experience of office set-up activities an advantage
* Knowledge of 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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