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Senior
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jobs
Experienced project associate specialising in Pharma
Sarah Neeson
,
Maidenhead, United Kingdom
Experience
Other titles
Skills
I'm offering
By nature, I am a conscientious person with a forward-thinking attitude, having utilized professional opportunities by taking full advantage of a natural aptitude for absorbing information and mastering new skills. I possess the ability to work efficiently both individually and as a team member in a pressurized environment. My personality combines enthusiasm to learn, with the added ability to adapt to new surroundings.
Markets
United States
(Remote
only)
United Kingdom
France
(Remote
only)
Germany
(Remote
only)
Industries
Language
English
Fluently
Ready for
Larger project
Ongoing relation / part-time
Full time contractor
Available
My experience
2020 - ?
job
Clinical Support Associate
Novartis.
Project Management, Project coordination, Finance, MS office, MS project, PROJECT PLANNING, Communication
2019 - 2020
job
Clinical Trial Associate
Simbec Orion.
Project Management, Project coordination, Clinical, Pharmaceutical, Administration, Communication
2018 - 2019
job
Account Support Coordinator, Oncology and BioPharma, Business Development, Europe
Covance.
I currently work for a Global Clinical Research Organisation based in Slough. I am primarily responsible for assisting the Business Development team, including the Executive Director, Account Directors and Account Manager, with the organisation and administration of the business development process.
Current tasks assigned to myself include, but are not limited to:
• Coordination of Business Development Team activities including hosting client meetings.
• Preparation for bid defences in conjunction with the BD team.
• Maintenance of study systems, files, forms and guidelines, including; Client Meeting tracking sheets and the Business Development team calendar.
• Organization of conferences - including team registration
• Updating Salesforce with details of new business opportunities.
• Arranging travel, meeting space and accommodation for the Account Director for client meetings and conferences.
• Organisation
• The maintenance and distribution of study-specific tracking reports.
• To support project meeting preparation, execution and collection/distribution of materials.
• To provide clerical and administrative support to project managers and assigned projects.
• To ensure all study documents are archived based on the appropriate guidelines and policy.
• To provide support and timely follow-up for audit and quality assurance activities. This includes the quality check of TMF project and site files.
• The maintenance of study information on a variety of databases and systems, both internally and externally.
Current tasks assigned to myself include, but are not limited to:
• Coordination of Business Development Team activities including hosting client meetings.
• Preparation for bid defences in conjunction with the BD team.
• Maintenance of study systems, files, forms and guidelines, including; Client Meeting tracking sheets and the Business Development team calendar.
• Organization of conferences - including team registration
• Updating Salesforce with details of new business opportunities.
• Arranging travel, meeting space and accommodation for the Account Director for client meetings and conferences.
• Organisation
• The maintenance and distribution of study-specific tracking reports.
• To support project meeting preparation, execution and collection/distribution of materials.
• To provide clerical and administrative support to project managers and assigned projects.
• To ensure all study documents are archived based on the appropriate guidelines and policy.
• To provide support and timely follow-up for audit and quality assurance activities. This includes the quality check of TMF project and site files.
• The maintenance of study information on a variety of databases and systems, both internally and externally.
Business development, Administration, Research, Salesforce, Account Manager, Hosting, Support, Quality assurance, Coordinator, Development, Organization, Audit, UP, Manager
2016 - 2018
job
Project Coordinator, Project Management
Syneos Health.
I previously worked for a Global Clinical Research Organisation based in Maidenhead. I was primarily responsible for supporting the Project Manager, Clinical Monitoring Project Lead and the Clinical Research Associates on all aspects of project management.
I directly corresponded with clients on a weekly basis to determine their requirements, agreed timelines for the completion of on-going activities and actively informed them of progress in relation to the collection of original documentation collected at sites during routine monitoring visits and close-out visits.
In relation to this, I was responsible for working with the Clinical Monitoring Project Lead and the Clinical Research Associates to collect original documentation from 49 sites across multiple countries in Europe. In preparation for the close out visits I was also responsible for completing a quality check of the paper Trial Master File across all 49 sites to determine which documentation was outstanding and to request the collection of these documents from Clinical Research Associates. Documentation received was then tracked in an inventory which was shared with the client. These inventories were also used by the client to write their respective comments, for which I was responsible for reviewing and providing clarity, confirmation or if it was not possible for me to do so, to contact the respective Clinical Research Associate for the relevant feedback.
Additional tasks assigned to myself included, but were not limited to:
• The set-up and maintenance of project files (electronic and hardcopy).
• The set-up and maintenance of the project plan.
• The maintenance and distribution of study-specific tracking reports.
• Supported project meeting preparation, execution and collection/distribution of materials.
• Provided clerical and administrative support to project managers and assigned projects.
• Ensured all study documents were archived based on the appropriate guidelines and policy.
• Provided support and timely follow-up for audit and quality assurance activities. This included the quality check of TMF project and site files.
• The maintenance of study information on a variety of databases and systems, both internally and externally.
I directly corresponded with clients on a weekly basis to determine their requirements, agreed timelines for the completion of on-going activities and actively informed them of progress in relation to the collection of original documentation collected at sites during routine monitoring visits and close-out visits.
In relation to this, I was responsible for working with the Clinical Monitoring Project Lead and the Clinical Research Associates to collect original documentation from 49 sites across multiple countries in Europe. In preparation for the close out visits I was also responsible for completing a quality check of the paper Trial Master File across all 49 sites to determine which documentation was outstanding and to request the collection of these documents from Clinical Research Associates. Documentation received was then tracked in an inventory which was shared with the client. These inventories were also used by the client to write their respective comments, for which I was responsible for reviewing and providing clarity, confirmation or if it was not possible for me to do so, to contact the respective Clinical Research Associate for the relevant feedback.
Additional tasks assigned to myself included, but were not limited to:
• The set-up and maintenance of project files (electronic and hardcopy).
• The set-up and maintenance of the project plan.
• The maintenance and distribution of study-specific tracking reports.
• Supported project meeting preparation, execution and collection/distribution of materials.
• Provided clerical and administrative support to project managers and assigned projects.
• Ensured all study documents were archived based on the appropriate guidelines and policy.
• Provided support and timely follow-up for audit and quality assurance activities. This included the quality check of TMF project and site files.
• The maintenance of study information on a variety of databases and systems, both internally and externally.
Project Management, Research, Project Manager, Management, It, Audit, Support, Quality Assurance, Coordinator, Organization, Monitoring, Audit, UP, Manager, ME
2013 - 2016
job
Senior Regulatory Affairs Administrator
PRA Health Sciences.
I previously worked as an administrative associate for a global clinical trial organization, supporting the global regulatory affairs team with various activities related to projects as well as essential administrative duties.
I was responsible for supporting the local and global regulatory affairs associates with submissions of clinical trial applications to both the Ministry of Health and to Central Ethic Committees, by preparing and organizing the necessary documentation required for submission. In accordance with sending out these submissions, an additional responsibility included ensuring that these submissions, along with the relevant communications received from the Ministry of Health and the Central Ethic Committees, were filed within an internal database which could be accessed by all of PRA's clients.
Additionally, I provided project support to global regulatory affairs leads, directors and to the vice president, by ensuring that all information stored internally, was compliant and up to date. I was assigned to provide administrative support to two of PRA's biggest clients, and my duties included attending client WebEx calls, which enabled me to gain a great understanding of their specific requirements, updating a client specific database which was used to capture upcoming submission activities on a global level, tracking planned, target and actual submission dates in an internal database, which was essential in helping local and global associates plan upcoming submissions.
As part of the regulatory intelligence team, I was involved with the implementation of a brand-new system which was used to gain clinical trial intelligence on various countries around the world.
I enjoyed being innovative and regularly provided input for the improvement of the new system by taking users' experience of the system into account, and then discussed potential changes with the department's directors. Additionally, I was also involved in training over 100+ colleagues who were required to use and update this new internal system to gain intelligence for various countries on a global scale.
I was also involved in updating internal webpages using Salesforce with essential information referred to by colleagues across the company, which concerned regulatory affairs and regulatory intelligence.
My additional responsibilities included but were not limited to; processing global translation requests, data entry, chairing meetings, writing meeting minutes, monitoring the team mailbox and fax machine, processing post, document filing and the completion of stationary orders.
I was responsible for supporting the local and global regulatory affairs associates with submissions of clinical trial applications to both the Ministry of Health and to Central Ethic Committees, by preparing and organizing the necessary documentation required for submission. In accordance with sending out these submissions, an additional responsibility included ensuring that these submissions, along with the relevant communications received from the Ministry of Health and the Central Ethic Committees, were filed within an internal database which could be accessed by all of PRA's clients.
Additionally, I provided project support to global regulatory affairs leads, directors and to the vice president, by ensuring that all information stored internally, was compliant and up to date. I was assigned to provide administrative support to two of PRA's biggest clients, and my duties included attending client WebEx calls, which enabled me to gain a great understanding of their specific requirements, updating a client specific database which was used to capture upcoming submission activities on a global level, tracking planned, target and actual submission dates in an internal database, which was essential in helping local and global associates plan upcoming submissions.
As part of the regulatory intelligence team, I was involved with the implementation of a brand-new system which was used to gain clinical trial intelligence on various countries around the world.
I enjoyed being innovative and regularly provided input for the improvement of the new system by taking users' experience of the system into account, and then discussed potential changes with the department's directors. Additionally, I was also involved in training over 100+ colleagues who were required to use and update this new internal system to gain intelligence for various countries on a global scale.
I was also involved in updating internal webpages using Salesforce with essential information referred to by colleagues across the company, which concerned regulatory affairs and regulatory intelligence.
My additional responsibilities included but were not limited to; processing global translation requests, data entry, chairing meetings, writing meeting minutes, monitoring the team mailbox and fax machine, processing post, document filing and the completion of stationary orders.
Writing, Training, Database, Salesforce, Support, Implementation, Health, Regulatory Affairs, Monitoring, Regulatory, Administrator, UP, Processing, President, ME
2012 - 2013
job
Office Assistant
R J Clyde Builders Ltd.
Office
2012 - 2012
job
Regulatory Coordinator
Allergan.
Coordinator, Regulatory
2010 - 2012
job
Regulatory Administrative Assistant
Abbott Laboratories.
Regulatory
2009 - 2010
job
Online Groceries Shopping Coordinator
Sainsburys.
Coordinator, Online
My education
Cox Green School
Secondary, Level 2 (Minor in Business)
Secondary, Level 2 (Minor in Business)
n/a
Secondary, N/a
Secondary, N/a
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