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    Senior Director, Data Services Quality Management - London, United Kingdom - Pharma Search

    Pharma Search
    Pharma Search London, United Kingdom

    5 days ago

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    Description
    Director of Project Delivery, Asia Pacific
    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

    Approximately two years ago, the decision was taken to create a new role within the global operations function focused on the development and management of PRA's key customers and oversight of international trials and programmes.

    Additionally, the client could benefit from a single point of contact for their operational and commercial needs.

    In executing this strategy, PRA set out to build a team of Project Delivery professionals who would work alongside operational and commercial groups to coordinate activities relating to specific accounts.

    Over the last 18 months, PRA have targeted experienced global study management and clinical operations professionals, both internally and externally, who have sought to leverage their clinical research knowledge and experience in a client facing role.

    Today, the Project Delivery team is 13 strong and is led by six General Partners worldwide.

    Their remit is to provide client management, leadership and project mentorship with the goal of providing outstanding customer delivery and developing a strong, long-term relationship with the customer.

    In the last few months, PRA have been awarded preferred provider status with a global pharmaceutical company and the need has arisen to recruit an additional Director, Project Delivery to the team.

    Reporting to the UK based General Partner, the role can be based at one of PRA's European offices or may be home based for the right candidate.

    PRA are seeking a professional with a life sciences degree who brings extensive experience in global phase I-IV clinical trial management and strong commercial skills.

    You will already be liaising with clinical research and procurement professionals at a senior level within the pharmaceutical industry and comfortable with managing a portfolio of multi-centre international studies.

    This is a unique opportunity to join a dynamic and growing business unit within one of the leading global CROs in a role which offers tremendous scope for career development and enhancement.

    Accountable for maintaining relationships (i.e. maintaining repeat business) with assigned Customer(s)/projects through excellence of project delivery of awarded projects whilst maintaining bid profitability.

    Frequent and routine (e.g. weekly) face-to-face and remote liaison with Customer contacts to review and discuss status (e.g. project successes, issues, opportunities) of awarded projects.
    Networking within Customer to extend contacts and develop business opportunities for PRA.
    Leads Project Status Reviews (PSRs) for assigned projects including risk assessment.

    Ensures maintenance of bid profitability through thorough review of projections of revenue, estimates of cost to complete and timely execution of contract modifications for awarded projects.

    Owner of content of materials to be used at bid defense meetings.

    Mentor Project Managers (all levels) leading assigned projects and provides feedback on performance to line-managers of Project Managers (Director of Project Managers).

    An undergraduate degree in health sciences from an accredited institution or international equivalent degree.

    Business related coursework (management, marketing, accounting, budgets, personnel management, negotiation skills, etc.) Demonstrated experience with clinical project development process, financial management tools, regulatory compliance (International Conference on Harmonization (ICH)-Good Clinical Practices (GCP)), data management, project scheduling and resource management, coordinating and scheduling team activities.

    Read, write, and speak fluent English, fluency in the language of the host country required
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