Clinical Study Manager - UK
Location: Uxbridge England
Description: GlaxoSmithKline is at present looking to employ Clinical Study Manager - UK right now, this job will be placed in England. Further informations about this job opportunity kindly see the descriptions. Basic qualifications:
- Degree life sciences, pharmacy, pharmacology, nursing qualifications or equivalent qualification
- Experience in a similar Clinical Research role! with a CRO or Pharmaceutical company
- Good knowledge of clinical research methods, SOPs and regulatory requirements
- Good communication skills, meeting chairing skills and ability to motivate others
- Organisational & planning skills, delivers to milestones
- Ability to think of novel ideas to speed recruitment, increase quality and plan contingencies
- Demonstrable ability to manage clinical trials
We are a science-led global healthcare company that puts patients first. Our innovative medicines, vaccines and consumer health products enable millions of people across the world to do more, feel better and live longer. Last year, we invested £3.9 billion in research and development to achieve our aims. Join us as a Clinical Study Manager within Pharmaceuticals and you can look forward to a worthwhile and fulfilling career. Great emphasis is placed on on-the-job! learning and development to help you to thrive in our open an! d inclusive environment. We also trust and respect our people, and reward their performance.
This is a UK only role, although the role will lase with other country studies this role involves purely working on UK only studies. The role also involves working across studies from phase II to phase IV and all therapy indications except Vaccines and Oncology. The usual number of studies is between 8-10 at any one time.
Key Accountabilities/Responsibilities:Accountable for delivery of designated studies through:
- Leadership of cross functional study-teams, including CRO teams where applicable
- Setting clear study team objectives which are understood and supported by all team members
- Matrix management and motivation of the study team to maximise productivity and performance within individual studies
- Engage proactively with regional/global study colleagues to ensure performance comparisons and key learnings from o! ther countries are implemented in UK
- Accountable for accurate MREC submissions
- Ensuring timely availability of study documentation and materials, including but not limited to IMP and all necessary approvals (including liaison with UK Regulatory Affairs)
- Preparation of study budgets and use of costing templates as appropriate
- Provide support for and where applicable drive contract and approvals negotiations with external suppliers, investigators and other parties
- Accountable for investigator selection and feasibility in conjunction with the CRS, Field Team Manager (if applicable) and Study Management Director
- Managing study specific resource requirements during the course of the study in conjunction with the Field Team Manager (if applicable) and Study Management Director
- Accountable for overall patient recruitment including contingency planning
- Track study progress against milestones at each stage of th! e study and ensure actions taken to deliver recruitment to target and p! lan
- Drive focus on data quality measures to ensure accuracy of patient data entered into e-CRFs and also data quality in other systems
- Oversee and where applicable take on the co-ordination of investigator and monitors’ meetings, when required
- Ongoing management and reporting of the study budget, accruals and forecasts
- Ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting)
- Review and regularly update all study databases to ensure 100% accuracy (e.g. e-Track)
- Work in collaboration with other GSK stakeholders, such as Medical Advisor and brand team members in maintaining relationships with Key External Experts as appropriate.
- Maintenance and accuracy of central study files through minimum of monthly Phlex checks
- Accountable for the distribution of Clinical Study Reports as required
- If required for the UK, generation of ! study summaries, synopses, protocols, reports and publications through liaison with external and internal stakeholders
- Forecasting and securing IMP and non IMP supplies in conjunction with Medical Operations.
- Study management responsibility
- Day to day management of specific study budgets
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
The closing date is 27th May 2013
Contact information:
You may apply for this position online by selecting the Apply now button.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to GlaxoSmithKline.
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This job starts available on: Mon, 13 May 2013 15:02:52 GMT