Closing Date: 12 Dec 16
Type: Full Time
Salary (£): On Application
> Who we are We’re innovation, curiosity and diversity – multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we’re constantly learning and growing – and seeking people who share these goals. ...
Who we are
We’re innovation, curiosity and diversity – multiplied by 80,000 professionals in 150 countries. As a global leader in research-focused healthcare, we’re constantly learning and growing – and seeking people who share these goals.
The Country Study Manager (CSM) provides leadership and local strategic planning and organisation to ensure the effective and efficient delivery of the operational aspects of one or more studies through all phases of study management (preparation, conduct, close-out).
The Country Study Manager (CSM) will have full accountability for all assigned studies at a country level including adherence to quality, timelines and budget in accordance with the appropriate quality standards including ICH/GCP/GPP standards, Roche SOPs, local operating guidelines and local requirements, as applicable.
The CSM leads and participates in the preparation phase of the study (feasibility, site selection, initiation) ensuring all other roles that support these activities both internally and externally contribute appropriately. You will be accountable for ensuring investigator site recruitment targets and timelines are realistic and adequate to ensure recruitment to overall country commitment and developing and actively managing study patient recruitment strategies. You will be accountable for the development of the local study budget, initial study resourcing forecasts and establishment of study level plans (including risk management plans) and ensuring that TMF (country and site level) documentation is Inspection Ready.
As a CSM, you will lead the Local Study Team and set the study team goals, ensuring these are in line with the operational strategy agreed by Clinical, Medical and Global/Local Study Management Teams.
You will be required to ensure patient safety and quality are maintained, seek input and escalate concerns appropriately as well as ensure monitoring activities are performed in accordance with study TMP and reports are timely, and reviewed.
You will coach and provide indirect line management support in partnership with the relevant line managers to Roche in-house study team members (i.e. Country Study Specialist and Study Start Up Specialist) by setting clear goals and expectations, monitoring performance, providing overall motivation, support, feedback and follow up to ensure team performance is fully optimised. The CSM will also provide oversight, leadership and support to CRO staff (Clinical Research Associates and Clinical Trial Assistants) to ensure overall delivery at the country and site level. The CSM interfaces regularly with local Roche Vendor Managers and CRO Management regarding feedback on CRO staff performance.
Your ability to build and maintain effective working relationships with key internal and external stakeholders, including Investigators, Local Medical Team, Global Study Team, other local departments, external vendors/CROs etc. is essential.
Who you areYou’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You will have proven clinical development experience on the operational aspects of conducting clinical studies which may include vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units.
You must be able to communicate clearly and accurately in both written and spoken English and have a demonstrated ability to interact with different professional levels of the research community.
Your strong leadership skills developed through leading multi-functional matrix study teams through all stages of clinical studies will be essential for this position, as will your experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans.
You will have substantial experience influencing and negotiating at all levels to achieve team delivery, which will be aided by your excellent written and verbal communications skills and demonstrated by your ability to present clear messages from complex information/data to all levels in the organisation.
You will be self-motivated and achievement driven and will have a demonstrated ability to prioritise and manage multiple tasks.
You must also possess strong computer skills, including the usage of MS Office software, web-based systems and databases.
Domestic and international travel required.
If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you. In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
To be considered for this position, please apply using the link below.
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.
Who we areOur UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
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