Carol Brownbridge has over 15 years of experience in the pharmaceutical industry, specializing in coordinating clinical trials and managing regulatory documentation. She excels at project management, customer service, and training colleagues. Her roles have included collecting documents for FDA submissions, liaising with investigators in 30 countries and 300 studies, and leading initiatives to improve processes and share best practices globally.
1. Carol Brownbridge
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Carol Brownbridge
Cheshire, |Tel 01625250911 | Mobile 07795514196
cybrow nbridge@hotmail.com | http://uk.linkedin.com/pub/carolbrownbridge
PROFILE
Forward thinking Study Delivery Associate with specialist expertise in the assembly of critical data to aid
the launch of new products for a global pharmaceutical company. Combines a thorough understanding of
modern office systems and processes with project co-ordination experience and excellent research and
development capabilities. An insightful and collaborative individual responding well to an ever changing
environment. Excelling in working on multi projects at different phases of development.
KEY SKILLS
Results Orientation - Collates information for submission to the FDA and other regulatory bodies to
determine whether and when drugs go to market.
Customer Focus - Operates on a proactive basis, constantly liaising with colleagues across the UK and
overseas, responding to cultural and communication differences to identify needs and negotiates
successful outcomes.
Drives Performance – Identifies opportunities to improve performance, including utilises resources more
effectively and facilitating key knowledge sharing through producing learning materials.
Systems and Processes – Utilises bespoke IT and Management Information Systems to maintain
accurate company records and to improve management decision making.
Developing Others – Mentors and coaches colleagues initiating and implementing training and
development interventions to improve understanding of systems and processes and best practice work
streams
Navigating change – Embraces new ways of working gaining the buy-in of team members to ensure
high levels of engagement and productivity.
SELECTED ACHIEVEMENTS
Managed and co-ordinated the transfer of 10 shared eroom over to sharepoint. This included indentifying
which rooms were still active, which needed transferring over for archive purposes, who need access to
the sharepoint and arranging access. Liaising with the IT team to ensure erooms that were not on the
migration listing were included. I identified a major global eroom that was not on the migration list and
arranged for to be put on the migration list.
Liaised with 30 countries and 300 studies to ensure each individual study was up to date in our database
system so that the business had an accurate record of the ongoing systems .
Liaised with colleagues in 23 countries and 222 sites to ensure all study related information and data had
been received and stored in the correct place.
Lead work streams on best practise, which resulted in hosting a workshop and rolling out this globally by
training colleagues.
Influenced over 60 doctors to buy-in to using a new IT system to submit their clinical trials. I also trained
them on how to use the new system and created workbooks for them to use.
Identified and implemented a solution to ensure the long term storage of CRF´s which forms part of the
FDA and European Clinical trials rules and guidelines.
Main point of contact for the Investigators to submit their proposals for clinical studies.
CAREER DEVELOPMENT
Study Delivery Associate | AstraZeneca Mar 2005 to Present
Pharmaceuticals
Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic
Partners, Marketing Companies and internal staff during the collection process to support effective
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delivery of numerous studies and its regulatory documents through finalization of the Clinical Study
Report (CSR).
Interact with Data Management Centre to facilitate the delivery of study related documents
Successfully managed and co-ordinated the update of over 200 studies this involved liaising with over 30
counties to ensure all their records were up to date.
Kept accurate records for all studies so that at any given stage there was a clear overview where all the
studies were up to.
Liaise with the Marketing companies to ensure any outstanding issues were resolved in a timely manner.
Ensured all records were complete for an FDA audit.
Worked on the Investigator Sponsor Studies to ensure key timelines and milestones were achieved.
Clinical Trials Assistant | AstraZeneca Oct 1997 to Mar 2005
Pharmaceuticals
Co-ordinating drug requisitions every month, organising meeting, updating various spreadsheets,
generating quarterly DNA’s for payments, co-ordinating CRF Books stock and delivery to investigator
sites, despatching key documentation to the Contract house, co-ordinating archive queries and facilitating
fast resolution, providing technical assistance in the setting and maintaining up of an electronic library,
producing a weekly newsletter for internal distribution, generating Pharma and Investigator newsletters
on a monthly basis.
Created and presented a best practise workbook/presentation that was rolled out internationally for the
closure of clinical studies to the GCP guidelines.
Created and designed tracking spreadsheets that were user friendly rolled out on global basis.
Co-ordinated and managed the collation of documentation needed for 23 counties with 222 sites.
Administration Officer | Data Protection Office May 1996 to Mar 1997
Data Protection
Responsibilities included: Liaising with companies in regards to correctly filling in documentation, entering
documentation onto database, answering telephone enquiries and following them through to completion,
checking forms have been completed properly, raising queries and chasing up outstanding queries until
completion.
Sales Support Co-ordinator | Schroder Leasing Oct 1995 to Dec 1995
Leasing
Responsibilities included: Managing accounts until completion, cross-referencing individuals and
companies for their credit status, collecting bank status information, checking documentation was
completed correctly, checking individual’s authorisation to sign, raising cheques and banking cheques,
dealing with customer enquiries, liaising between customer and supplier, confirming equipment had been
delivered and was in correct working order, ordering company accounts.
Processed £2 million pounds of completed transactions
Customer Service Co-ordinator | De La Rue Jul 1995 to Oct 1995
Banking
Responsibilities included: Managing accounts until completion and liaising with the banks, chasing up lost
orders, dealing with and completing until resolution customer complaints, co-ordinating engineer’s
appointments with the delivery of machinery needed, contact point for banks and large accounts
Became the main point of contact for several of the banks
EDUCATION & QUALIFICATIONS
University of Central England - Bsc Industrial Information Technology (2 years study)
A Levels: History, British Government and Politics, English Literature
G.C.S.E: 7 grades A – C including English and maths