- Represents GSSU on cross-functional and client levels.- Completion of initial and ongoing risk identification, communication, and ongoing risk management during the start-up phase.- Management of start-up team resources.- Management of start-up financials for project to maintain within scope and budget.- Oversees TMF Readiness and Completeness through activation- Primary liaison and primary point of escalation for project start-up issues for allocated countries/globally- Conducts internal calls with local team and Start-Up calls with Clients- Establishes site activation forecasts and ensures all critical path activities are on target.- Oversees compliance and maintenance of ICON systems and works with local team members to resolve any issues- Oversees local team to ensure local authority submissions and approvals are completed per country/region as applicable- Oversees site identification and recruitment activities for allocated countries/globally- Develops Essential Documents pack and conducts training with local team. Oversees the local team ensuring essential documents for all relevant regions are developed, collected, reviewed and tracked, according to project processes and timelines.- Provides timely status reports on project start-up activities for internal and client teleconferences, and during monthly project review meetings with the SSU VP, Directors and Managers- Collaborates with global and local regulatory teams to ensure submissions to Competent Authorities, Central Ethics Committees, and other central agencies are planning and completed in accordance with site activation timelines- Development and maintenance of Study Start-Up Plan.

• Performs investigator recruitment activities including collection and review of Confidentiality Agreements and Feasibility Questionnaires.• Assists Clinical Research Associates with scheduling Pre-Study Site Visits and Site Initiation Visits.• Prepares the Investigator and Pharmacy Site Files, localising site level documents as needed.• Utilizes Clinical Trial Management Systems to ensure investigator recruitment activities, documents and communications are accurately tracked.• Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory requirements, including distribution and implementation of submissions and amendments.• Files site level documents in the study TMF in a timely manner and performs TMF reviews.• Assists the CRA with site management activities, including resolution of investigational site/data queries• Liaises with the wider study team and attends weekly calls to provide guidance on local requirements, discuss site issues and updates.• Localises country level Informed Consent templates and patient facing materials for individual sites• Performs study duties in adherence to the protocol, project Plans, study processes & requirements and ICH-GCPNotable Achievements:• Independent Essential Document Reviewer• One of the NIHR Relationship managers for the company, which involves rolling out new processes and delivering training presentations to new starters.• Part of a Focus Group made up of UK Start-up, Contracts, Regulatory and Clinical Operations teams

Functional Team Lead (FTL) for a team of 12 Project Associates working on a large program of Inflammatory Bowel Disease studies.Project Associate FTL Responsibilities (In addition to the responsibilities listed below for the Project Associate role):• Oversight of Project Associate roles & responsibilities including individual and team Burn Rates & study allocation• Oversight of Study Compliance Metrics• Onboarding new team members onto the studies• Management of the Project Associate Task List, including oversight of task allocation and performance• Hosts regular meetings with Project Associate team to provide updates and progress and discuss any issues.• Attends regular meetings with the project manager to provide updates, discuss ongoing tasks and escalate any issues with the Project Associate team.• Attends regular calls with the wider study team and the sponsor and provide updates where required• Creates process documents for new tasks and updates to current process documents for existing tasks where required. Distribution and follow up with the project associate team as necessary• Review of current/new project plans to determine any process updates for the Project Associate team• Periodic review of the Project Associate task list to determine if frequency of current tasks is still appropriate and propose task retirements to the project management team as needed.

Responsibilities:• Performs investigator recruitment activities including collection and review of Confidentiality Agreements and Feasibility Questionnaires.• Assists Clinical Research Associates with scheduling Pre-Study Site Visits and Site Initiation Visits.• Prepares the Investigator and Pharmacy Site Files, localising site level documents as needed.• Utilizes Clinical Trial Management Systems to ensure investigator recruitment activities, documents and communications are accurately tracked.• Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory requirements, including distribution and implementation of submissions and amendments.• Files site level documents in the study TMF in a timely manner and performs TMF reviews.• Assists the CRA with site management activities, including resolution of investigational site/data queries• Liaises with the wider study team and attends weekly calls to provide guidance on local requirements, discuss site issues and updates.• Localises country level Informed Consent templates and patient facing materials for individual sites• Performs study duties in adherence to the protocol, project Plans, study processes & requirements and ICH-GCPNotable Achievements:• Attended Site Monitoring Visit with Clinical Research Associate• Excellent feedback on numerous occasions regarding pro-activity and high quality of work completed across 11 protocols simultaneously.Protocol Therapeutic Experience gained:• Immunology, Oncology, Hematology, Hereditary Disorders

Responsibilities: • Working with the Project Manager/core study team to ensure that project deliverables are completed in accordance with contract and client expectations.• Facilitating project team and client meetings/teleconferences, e.g. scheduling, booking resources and preparing meeting materials, agendas and meeting minutes.• Facilitating internal and external system access for study participants.• Developing and maintaining project tracking tools and generating project status reports.• Generating and maintaining project specific documents, e.g. project specific training plan, organisational charts, contact lists.• Coordinating project specific training setup, maintenance and assignment to team members through internal systems.• Facilitating project team compliance and follow up, e.g. project specific training and CTMS compliance.• Assisting with TMF maintenance and ongoing QC, as well as migration activities.Notable achievements:• Mentor to 2 new Project Associates.• Involved in organisation of Sponsor-PRA October 2017 F2F meeting in London for the Gilead IBD program.• Part of the Training Management Subject Matter Expert team within the Project Associate team, with the following responsibilites:- Sharing knowledge and information with other Project Associates to enhance performance within the EAPA Project Associate group- Standardising the mentoring process across the EAPA PR group- Hosting monthly system training sessions with groups of new starters- Creating useful training material / presentations and centralising key information- Helping to resolve complex issues

Therapeutic Area: PsychiatryIndication Group: Eating DisordersPrimary Indication: Anorexia Nervosa/Bulimia Nervosa• Providing care for adolescent patients aged 11 to 17 with eating disorders.• Undertaking observations and supervision of patients.• Providing patients with individually tailored calorie specific meals.• Maintaining a safe environment. • Making daily clinical notes regarding patients mood, activities and behaviours.• Keeping up to date with mandatory training.• Building and maintaining professional relationships with patients as well as providing support.• Assisting with Nasogastric feeds.

• Assisting customers on the shop floor, telephones and at the till point in a polite and professional manner.• Maintaining high standards of merchandising, replenishment of stock and general maintenance.• Undertaking various quarterly end of season sale roles including preparation of the shop floor and stock rooms, stock-taking and managing a sub-team on sale preparation days. • Willing to approach customers and able to close a sale by matching the customer's needs to the right product whilst building a great rapport with them.• Working as part of the sales team to provide excellent customer service.• Excellent product knowledge across all four departments (Womenswear, Childrenswear, Menswear & Home).• Adherence to all Company policies and procedures.

• Provided an excellent standard of care for children aged 2-3 years-old.• Communicated with colleagues, parents and children in French.• Organised activities, including crafts, games, stories and songs.• Followed and implemented the child safety policies and procedures set out by the organisation.• Ensured that all daily routines are adhered to, including mealtimes and naptimes.• Maintained a high level of awareness as well as high standards of health and safety.

• Assisted teachers with classes of 30 French pupils aged 3 - 11 years-old.• Independently taught groups of 7 - 15 pupils for 10 - 30 minute sessions.• Supported and enhanced students' knowledge of English language and culture using a range of media and materials.• Developed planning, time management and organisational skills.• Improved French language and communication skills.• Learnt to overcome obstacles and deal with the unexpected, gaining flexibility and creativity when problem solving.