Sherri Griffith's Location
King of Prussia, Pennsylvania, United States, United States
Sherri Griffith's Contact Details
Sherri Griffith work email
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About Sherri Griffith
Regional clinical study manager responsible for managing and motivating cross-functional teams in a fast-paced, milestone driven environment by utilizing strong organizational, technical and interpersonal skills. Experience includes coordination of study activities and management of budgets, vendors and sites. Strengths include detail-oriented, resourceful, ability to effectively multi-task and identifying study risks and develop workable solutions.
Sherri Griffith's Current Company Details
Sherri Griffith Work Experience Details
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Project ManagerIcon PlcKing Of Prussia, Pa, Us
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Project ManagerIcon Strategic Solutions Jul 2021 - PresentDublin , Gb -
Project ManagerPra Health Sciences Nov 2015 - Jul 2021Raleigh, North Carolina, UsManage study start up activities for multi-site, Phase 3b clinical trial in treatment of cardiovascular disease (Dyslipidemia) and ensure study is conducted and recorded in accordance with protocol, standard operating procedures (SOPs) and Good Clinical Practice.- Successfully accelerated regional start up activities to support project team request to perform site initiation visits (SIV) 6 months prior to originally scheduled SIV timelines.- Contributes toward recruitment strategies in partnership with other functional areas to ensure milestones are met.- Coordinated collection and preparation of site initiation visit training slides and participated in the presentation of SIV training to Clinical Research Associates. - Provides quality control review and clinical input on CRF, CRF completion guidelines, monitoring plan, Investigational Product Instruction Manual (IPIM) and other study related documents to ensure accuracy and timelines for initiation of trial. - Partners with clinical supplies in ordering, packaging, and delivery of study drug to investigator sites. - Ensures timely and accurate documentation and communication of study progress and issues. Takes action to resolve issues that are within scope and elevates issues to project team when necessary.- Composed country specific ICFs and subject facing materials. Managed review and approval process of 175 site specific ICFs. Coordinated translation of country ICF.- Prepares and submits country IRB application along with other study specific documentation to central IRB to obtain approval to conduct the study. - Coordinates tracking of budget and contract process activities associated with site start up.- Participates in various clinical study team meetings as well as vendor meetings.- Supports and monitors vendor activities, relationships and training. -
Regional Study Manager, OncologyNovartis May 2015 - Oct 2015Basel, Baselstadt, ChGSK oncology acquisition to Novartis responsible for outsourcing study activities to CRO’s and retaining specific oversight of monitoring and data management.- Created strategies to reduce significant eCRF data queries which resulted in 85% drop in overall queries and 100% decrease in queries over 21 days old.- Planned, prepared and presented slides pertaining to protocol overview, data management and study specific monitoring plan in an effort to outsource studies to CRO.- Managed collaboration between CRO’s, Novartis and GSK teams to ensure all cross-functional teams have clear understanding of responsibilities and revised processes within new integrated team. -
Clinical Operations Study ManagerGsk Mar 2014 - Apr 2015Brentford, Middlesex, Gb- Managed study activities for multi-site, Phase II and Phase III clinical trials in treatment of oncology - Problem-solved regional study issues and risks with exceptional commitment to quality, communication and persuasion skills- Managed monitoring and data management activities of regional clinical research associates to include weekly dissemination of project related activities and study timelines, review of monitoring reports and task performance reports- Coordinated and led United States monitoring team to deliver quality, clean data within tight timelines in an effort to meet safety and post marketing requirement (PMR) data cut-offs. Achieved 100% on-time completion rate for all query resolution data cut-offs.- Evaluated, approved and tracked site and vendor invoices based on applicable contracts and within study budget- Reviewed and approved site-specific informed consents for Institutional Review Board- Maintained Country Trial Master File per corporate standard operating procedures (SOPs) and guidance- Interacted with central IRBs and other external vendors- Provided assistance to Regulatory Affairs as necessary for filing and other required compliance requirements- Ensured all assigned trials were conducted in accordance with company SOPs and ICH/GCP guidelines -
Lead Clinical Study AssociateGsk Jan 2013 - Mar 2014Brentford, Middlesex, Gb- Integrated creativity and past experience to develop and improve CSA processes and procedures to enhance study delivery.- Developed and delivered training material and processes for CSA tasks and GSK systems.- Built relationships with multiple internal and external partners to understand their perspectives to enable and drive changes to overcome study obstacles.- Challenged CSA support and study teams to be flexible in seeking and making informed decisions while always putting customer and patients first. - Participated in interviewing, hiring and training of new CSAs.- Continued to perform responsibilities of global CSA
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Global Clinical Study AssociateGsk Dec 2010 - Jan 2013Brentford, Middlesex, Gb- Assisted study team in their mission to successfully submit regulatory applications in EU and US. Completed listing of clinical references to support Australia in their pre-submission application- Supported multiple groups prior to and during FDA audit to include monitoring, clinical, safety, quality and clinical supplies groups - Managed tracking of study biopsy samples and pathology reports related to cutaneous events. Coordinated and led telephone discussions between GSK and vendor to review events verses samples received. Created power point presentation slides to be presented at CEC meeting- Managed communications with vendors in regard to shipping of study related investigator product and supplies - Developed a shipment and tracking process for ECGs. Created power point slides to present ECG process during US, EU and INT monitor training sessions- Assisted in managing randomization to ensure recruitment goals were on target by tracking subject mutations, cohorts, PK samples, etc. - Assisted in developing and organizing Study Procedure Manual- Completed UAT testing and training for two integrated critical clinical systems central to GSKs Simplifying Clinical Development initiative- Reconciled internal and external system interaction issues- Reviewed status of centres in GSK ClinicalTrials.gov to guarantee accurate dissemination of information to public- Supported DM in resolving identified queries to achieve data analysis timelines- Disseminated study updates to monitoring and/or study conduct team as appropriate
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Clinical Study Associate (Csa)Gsk Jun 2008 - Dec 2010Brentford, Middlesex, Gb- Collected, reviewed and submitted required documentation to regulatory operations throughout study- Traveled to clinical research organizations (CROs) to conduct file review, reconciliation and other closeout activities as appropriate- Liaised with meeting planning vendor in logistical planning of study meetings (Investigator, CRO, and Coordinator). Assembled materials and attended to support investigator meetings- Developed and maintained invoice tracker. Reviewed and reconciled invoices and facilitated investigator payments- Assisted in preparing and routing Clinical Study Agreements (CSAs) and ensured fully executed agreements were in place prior to drug shipment and payment- Ordered, distributed, managed and tracked study conduct tools and non-drug clinical supplies- Created and maintained sponsor study records according to FDA/ICH Guidelines and internal SOP’s- Communicated with regulatory and CTS to coordinate shipment of clinical supplies- Reconciled FIDS, CARDS and sponsor study records to provide documentation in support of modular appendices for Clinical Study Reports- Assisted with review of informed consents and highlight changes for Study Manager- Participated in site selection process- Provide operational support for delivery of assigned studies or programs on time- Adhered to Clinical model, collaborating with internal key matrix partners and external customers- Provided support, expertise and acted as central point of contact for eTrack application for Business Area. Communicated eTrack relevant information to supported area in a timely manner when requested.
Sherri Griffith Skills
Oncology
Pharmaceutical Industry
Cross Functional Team Leadership
Project Management
Strategy
Gmp
Microsoft Office
Strategic Planning
Microsoft Excel
Customer Service
Process Improvement
Sherri Griffith Education Details
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York College Of PennsylvaniaBusiness Management
Frequently Asked Questions about Sherri Griffith
What company does Sherri Griffith work for?
Sherri Griffith works for Icon Plc
What is Sherri Griffith's role at the current company?
Sherri Griffith's current role is Project Manager.
What is Sherri Griffith's email address?
Sherri Griffith's email address is sl****@****ast.net
What is Sherri Griffith's direct phone number?
Sherri Griffith's direct phone number is +161026*****
What schools did Sherri Griffith attend?
Sherri Griffith attended York College Of Pennsylvania.
What skills is Sherri Griffith known for?
Sherri Griffith has skills like Oncology, Pharmaceutical Industry, Cross Functional Team Leadership, Project Management, Strategy, Gmp, Microsoft Office, Strategic Planning, Microsoft Excel, Customer Service, Process Improvement.
Who are Sherri Griffith's colleagues?
Sherri Griffith's colleagues are Tara Kennedy, Nadia I., Marija Kostic, Durvesh Singh, Kristóf Bányai, Bryttani S., Klea Metschke.
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