- Entry level
- No Education
- Salary to negotiate
Local Clinical Support Specialist
As Local Clinical Support Specialist, you will administer, maintain and co-ordinate the logistical aspects of operational support for clinical studies according to ICH GCP, international and local regulations and relevant GSK written standards. You will act as a pivotal point of contact for the local and international Clinical Operations Staff. You will be responsible for assisting the local study team in the ongoing planning, execution and close out of the study. You will also be responsible for the contractual and financial aspects of study start up such as setting up clinical study contracts and budgets with hospitals, making sure payments are processed in time, and monitor compliance processes. You will be owner of and accountable for creation, content, implementation, and maintenance of SOPs, TUGs.
- You assist local study teams by planning of start-up of sites involved in clinical studies within agreed budget, timescales and in accordance with GSK written standards and ICH GCP. Accountable that Green light process for site initiation is done accordingly to milestones.
- You are responsible to manage all logistical aspects of clinical studies according to GSK operating standards and good clinical practice and to ensure that studies receive the support needed to meet timelines and budget.
- You are responsible for accuracy of study systems in which the CSS is accountable for the adequacy of the data that they receive or produce themselves, also for internal colleagues within the GICCO organization.
- You are accountable for acquiring/maintaining an optimal level of knowledge of GSK tools and systems to effectively manage them. You arethe single point of contact for local study teams for study support questions.
- You maintain effective communication and working relationships with site staff, above country colleagues and other GSK staff. This is to make sure the GSK study team has the necessary data and documents, in time, according to ICH GCP R2, to perform the study. Why you?
We are looking for professionals with these required skills to achieve our goals:
- Experience in pharmaceutical industry or health related field
- Proficiency in multiple software applications as Vault Clinical and CARS
- Ideally 3-5 years working experience within the clinical development environment with process and FDA/ICH GCP regulations.
- Solid understanding and knowledge of financial aspects related to invoicing and payments
- Experience within Finance and Contracting study sites
- Good knowledge of clinical study conduct processes
- Solid knowledge of GSK’s written standards
- Good written and verbal communication skills in EnglishAND Dutch
- Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook) Preferred Qualifications:
If you have the following characteristics it would be a plus:
- 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, experience and maintenance of relevant operational procedures, systems and quality guidelines regarding clinical studies
- Financial experience with clinical study contracts, budgets, payments, accruals and oversight
- Ability to work in international environment. Cultural awareness is essential.
- Accountability for own actions/decisions
- Able to work independently in local- and international teams
- Conscientious and high quality delivery of work even when under pressure
- Professional attitude with good customer focus
- Flexible and responsive to new ideas in a changing environment, in work processes as well as in IT programs
- Knowledge of Management Monitoring and Quality Checks