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Job description

We are looking for a Lead Local Clinical Support Specialist! You will provide administration, maintenance and co-ordination of logistical aspects of operational support for clinical studies according to ICH GCP, international and local regulations, and to relevant GSK written standards. The LLCSS acts as a pivotal point of contact for the Country Clinical Operations Staff.

Key Responsibilities:
• Responsible for assisting S/CRA and S/LSM with preparation, collation, review and tracking of all documentation required for approvals processes (e.g. regulatory, ethics, green light process etc) for clinical trial sites. Ensure all official requirements of the RA and ECs during the course of a study are met in a timely manner.
• As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks. Assist S/CRA and S/LSM with study related activities such as assisting with scheduling study team meetings and may assist with producing minutes for study-related meetings, assembling training and study materials, and other tasks as required.
• Responsible for preparing the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist the S/CRA and S/LSM with maintaining the sponsor files during the life of the study. Responsible for archiving at the end of study in accordance with relevant GSK SOPs, policies and local regulatory requirements.
• Accountable for acquiring/maintaining an expert level of knowledge of GSK clinical study tracking systems to provide technical support and appropriate system Clinical Induction training to S/CRA and S/LSM. Maintain information in eTrack, and clinical safety database, to reflect current participating centres (including all contact details, contracts and reports) and lists of submissions to RA & ECs, and of shipments to centres.
• Is the initial point of contact for S/CRA and S/LSM with study and site related processes (e.g. handling of data queries). Proactively identifies issues and raises them to take necessary corrective action to ensure smooth and rapid progress of studies.
• Responsible for accuracy and currency of eTrack system data by the monitoring of study milestones at each stage of the study, amend inaccurate milestones and ensure that all issues are communicated and escalated appropriately. Work with the Local Expert Users group to gain expert knowledge and provide eTrack local expert support as an initial point of contact for the S/CRA and S/LSM. Responsible for communicating business process updates in eTrack appropriately.
• May assist in the planning, logistics and preparation of local Investigator meetings (travel arrangements; and assist with preparation and distribution of study related presentation material etc).
• Acquire/maintain an appropriate level of knowledge to support the financial aspects of clinical studies, GSK's financial tools and systems to enable the study teams to effectively manage the clinical study payments. Provide tools to study teams to enable the tracking of clinical study related payments to study sites and Investigators. .
• Responsible for working with the S/CRA for the management of study materials, non-IMP and IMP supplies - distribution, ordering, tracking, storage, reconciliation and destruction using external vendor.
• Maintain effective communication and working relationships with in and above country colleagues, other GSK staff, Investigators and other site staff.
• Provide support for study team in the event of an audit and where appropriate, assist with the resolution of any actions
• Participate in and help drive projects and initiatives upon request, or taking on department-wide tasks in order to contribute to the optimisation of processes, tools and systems. Also act as "champion" for specific tasks. Can serve as SMEs as appropriate.
• May assist Head of Clinical Support (HCS) with management of individuals in the team, escalating challenges encountered to ensure timely resolution.
• Adhere to GSK written standards, processes and ICH GCP guidelines. Keep up to date with all the changes and requirements attending appropriate training sessions. Participate continuously in relevant training courses to improve personal/professional skills.
• Share best practices within the LOC and with colleagues in other LOCs.
• Responsible for supporting multiple studies simultaneously and must prioritise appropriately to meet business needs to ensure delivery of results.
• Provide cover for colleagues in the clinical support team as required. Assist with other departmental support activities as requested.
• Engage and liaise with external CROs on specific study level activities.

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

Closing date for applications: COB - 28th of May 2019

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Thank you for your interest in this opportunity.

*LI-GSK

Why You?Basic qualifications:
o Scientific degree, e.g. life science, medicine, clinical research, pharmacy etc; or equivalent experience.
o A good understanding of GSK tools and system including an understanding of the lifecycle of a study and ICH GCP guidelines.
o Given the nature of the job and personnel responsibilities, must be able to convey GSK positions and requirements to a highly educated external partner group.
o Proven experience in pharmaceutical industry or health related field
o Thorough understanding of the clinical development process and FDA/ICH GCP regulations
o Solid understanding and knowledge of financial aspects related to invoicing and payments.
o Good knowledge of clinical study conduct processes.
o Solid knowledge of GSK's written standards
o Has good written and verbal communication skills in English and local language.
o Proficiency in multiple software applications. Possesses advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook).

Preferred qualifications:
o Excellent technical/IT skills. Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK systems/software. Knowledge of relevant operational procedures, systems and quality guidelines regarding clinical studies.
o Self motivated with ability to work, solve problems and make decisions unsupervised with limited instruction.
o Good communication and organisational skills with ability to interact well with all levels of management and staff (internal and external).
o Able to work ethically, plan, organise and manage priorities.
o Accountability for own actions/decisions
o Able to work independently as well as in a team.
o Recognises potential obstacles and works to resolve them within set timelines, takes responsibility for own actions
o Conscientious and high quality delivery of work even when under pressure
o Effective at technical problem solving.
o Professional attitude with good customer focus (internal and external)
o Flexible and responsive to new ideas in a changing environment.

Why GSK?:
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

Contact information:
You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Learn more about GlaxoSmithKline

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