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    Legal Director - London, United Kingdom - Pharma Search

    Pharma Search
    Pharma Search London, United Kingdom

    1 week ago

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    Description
    PRA International is one of the world's leading Global Clinical Research Organisations.

    PRA have managed to continually build and enhance their reputation through delivering a service that is reliable, with a high level of therapeutic expertise and global access to knowledge.

    This is enhanced by having a wealth of CRO, clinical and product development expertise within their senior management, all of whom work closely alongside their customers.

    Established in the late 1970's with name changed to Pharmaceutical Research Associates Inc., in 1981 with focus on data management in Virginia, USA.

    In 1991, PRA expanded its service offering to include clinical trial management and opened their first European location.
    In 1997, PRA acquired International Medical and Technical Consultants (IMTCI), a CRO based in Lenexa, Kansas. This increased PRA International's clinical trials leadership, expertise and experience within the key therapeutic areas of allergy and respiratory. Additionally they gained a Phase I facility.
    This acquisition enhanced their regulatory expertise and expanded PRA's trial management footprint in Europe.

    This further enhanced PRAs capability in Europe, across a number of therapeutic areas within clinical trial management, project management and quality assurance.

    In 2002, PRA acquired Staticon International Espana, an established CRO in Madrid, Spain, further developed their service offering in Europe and in particular bringing enhanced capability in electronic data capture and management.

    In June 2006, PRA acquired Pharma Bio-Research, an early phase clinical development and bioanalytical laboratory company based in The Netherlands, forming the basis for the group within PRA now known as Early Development Services.

    In October 2007, PRA acquired Pharmacon, a clinical research organisation based in Berlin, Germany.

    Specialising in Phase I studies with patients in several Central European countries, this was an important step in PRA's Early Development Services plan to further strengthen its position as an industry leader.

    Consistent and measurable quality in all they do
    Outstanding service and flexibility to meet customer requirements
    Project Management
    Medical monitoring and drug safety
    Data management
    Analysis and reporting
    Medical and scientific publications
    Regulatory filings
    Food effect
    Interaction studies with drugs and food
    Drug Safety Management
    Processing and reporting of adverse drug reactions (ADRs)
    Global database pooling and integrated summaries of safety
    Consulting and system analysis
    Electronic Regulatory Submissions
    Project Management
    Responsible for clinical operations activities and staff within the unit(s).

    Mentors and leads the clinical operations management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices.

    Provides leadership in the implementation of PRA's quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy.

    Sets overall direction, strategy and performance standards for multiple job disciplines to ensure that project profitability targets are achieved
    Schedules and reviews project tasks to ensure high quality product is delivered on time and within budget
    Ensures services provided to clients are compliant with PRA's policies, procedures, SOPs, ICH-GCPs, client contractual expectations and country specific regulatory requirements
    Manages operation budget for the unit (s)
    Mentors and develops employees to expand employee performance levels and ensure retention of high performing PRA employees
    Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
    Accurately projects resource needs to ensure timely hiring of clinical operations staff
    Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/project objectives are achieved
    Establishes processes and participates in PRA's Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
    Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
    Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic specific nuances while identifying potential impacts of the same to budget
    May function as legal representative for PRA in selected countries as appropriate
    Broader focus on moderate to complex projects. Strategic focus for all projects independent of degree of complexity. Undergraduate degree, or its international equivalent, in clinical science or health-related field from an accredited institution, or equivalent work experience required
    Extensive experience using computerised information systems required, experience with PC-Windows, word processing, and electronic spreadsheets required
    Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
    Read, write and speak fluent English, fluent in host country language
    Competitive basic salary
    Bonus
    5% non-contributory pension
    Life Assurance (4 X base salary)
    25 days holiday
    If you are interested in this role, please visit our website or send your CV to -search.
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