Prepares, reviews and coordinates local EC submissions in alignment with the global submission strategy. Supports the preparation of local MoH submissions as applicable, in alignment with the global submission strategy. Coordinate with internal functional departments to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines. Prepares site specific Patient Information Sheet/Informed Consent form documents. Has contact with investigators for submission related activities or act as a key contact at country level for either Ethical or Regulatory submission related activities. Responsible for preparing Regulatory Compliance Review packages, including working with the SIA CRA as applicable. Assists with the development of country specific Patient Information Sheet/Informed Consent form documents.

Successfully working within a fast paced, ever changing environment on multiple project teams ensuring that client deliverables are achieved in a timely manner and within budget, whilst maximising profit for the company. Assisting Project Managers on large multinational studies to supervise and coordinate the administrative and clinical project activities within the clinical study and assist in the clinical deliverables of the project being met. Compiling, analysing and taking action on project metrics and key quality indicators and thorough maintenance of multiple project databases to ensure real time data is available to internal and external team members. Responsible for leading a team of Project Assistants on key client deliverables and being a front of house contact for all client project needs.Ensure that project documentation and standard work processes are audit ready at all times and adhering to all confidentiality policies, procedures and federal regulations.Thorough understanding of project administration. Leading training within the Project Assistant team and mentoring new starters.• Promotion within the first year of joining the company• Performance recognition reward in August 2013• Voluntary and independent completion of the in house leadership programme

Providing consistent excellent customer service whilst promoting products and services to suit individual customer need. Meeting both team and individual goals and targets whilst still dealing with customer enquiries efficiently and thoroughly. Dealing with complaint resolution and difficult situations with understanding and empathy at all times to ensure the customer’s experience was always to the highest standard. Providing training to the other members of staff on LTSB products and systems and taking on administration tasks for a team of eleven to ensure accuracy of work on customer accounts, whilst adhering to strict FSA regulatory ruling.Monitoring key performance indicators for the team and following up with additional training as and when necessary.