Carol Brownbridge CV linked in
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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.
Carol Brownbridge CV linked in
- 1. Carol Brownbridge Page 1 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
- 2. Carol Brownbridge Page 2 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