Francis deGraft-Dickson
Parsippany,NJ
Summary
Developed and implemented a pragmatic recruitment effort to encourage as well as hasten the screening and randomization of study subjects, monitoring plans Consistently participated in special projects including data analysis, data migration onto SharePoint application and user acceptance test (UAT) to enhance CREDI functionality and project management Ensured trial sites received packages and supplies on time and in the right conditions, observed temperature excursion procedures Extensive experience processing Trial Master File (TMF) documentation using different tools and platforms such as Documentum and applications including Veeva, FirstDoc and Livelink (electronic document management systems - EDMS) Assisted in clinical sourcing to support Phase I-IV clinical trials and related projects Graduate degree in Clinical Trials Management
Overview
22
22
years of professional experience
Work History
Professional Development
Contractor
Seqirus Corporation
09.2021 - 01.2024
- Format documents and ensure that they meet technical specifications required for publishing
- Perform Quality Checks of clinical and submission documents
- Assist the Medical Writer to collate documents and maintain electronic filing
- Contribute to the Medical Writing projects in co-ordination of reviews
- Perform Quality Checks of information for protocol registration and disclosure results posting
- Participate in Company Confidential Information redaction and Anonymization of documents submitted to Health Authorities.
contractor
Merck Pharmaceutical Corp
02.2021 - 08.2021
- Review of electronic batch documentation of clinical finished goods to ensure clinical supplies are incompliance with cGMP and SOPs, all focused for regulatory submissions – biologics, vaccines, combination products
- Clinical suppliers specifications, labeling, storage
- Electronic records for regulatory submissions for IND or CTA (clinical trial application) in relation for clinical protocols – either join venture or independent study
- Involved in the process of vendor selection, contract negotiation and close-out of agreements.
Technical Editor and Copywriter
Inner Metamorposis
04.2020 - 01.2021
- Provided guidance and support to the team to develop the publication and reporting strategy
- Worked with scientific content team to conduct literature searches, help to manage the literature database
- Prepare literature reviews for clients
Senior Clinical Portfolio Specialist
Novartis Pharmaceuticals Corporation
10.2018 - 10.2019
- Manage end-to-end operations related to study start up and clinical documentation (CTMS/eTMF) to facilitate 23 trials in oncology and neuroscience
- Ensure compliance with ICH, GCP, and FDA regulations by overseeing IMPACT clinical trial management system (CTMS) data entry, and document management lifecycle of trial master file (TMF) at country, site, and patient level
- Liaise between Sponsor (Novartis) and each Investigator sites in all the trials, provide supplies, support recruitment efforts, review ICFs to identify the required element, manage external vendors operations
- Participated in vendor meetings, clinical trial team (CTT) meetings taking minutes and sharing with team and preparing agenda for meetings in addition to preparing presentations for meetings and training
- Govern multiple operations, such as release, follow-up, and tracking of Full Regulatory Package (FPP), amendments, investigator brochures, and informed consents aimed at initiating sites and obtaining IRB approval
- Work directly with Central IRB and local IRB/IECs to obtain EC approval for the Final Protocol, Amendments and ICFs among other documents
- Maintained quality standards for eTMF documents by performing regulatory document QC and reconciliation activities, including auditing and lifecycle of CREDI to ensure document quality (legibility, naming conventions, etc.) standards are maintained for eTMF documents
- Updated and deliver trial site setup for global clinical planning and tracking database (IMPACT) aimed at improving operations
- Developed and maintain master investigator lists for all clinical trials during site selection and approval process
- Identify and resolve study related issues
- Assisted in clinical sourcing to support Phase I-IV clinical trials and related projects
- Involved in the process of vendor selection, contract negotiation and close-out of agreements
- Key Contributions:
- Delivered exceptional support to field monitoring and project management organizations by implementing
- CTMS and TMF data, while interfacing between sponsor and vendors
- Supported eCTD documentation for submission to health authorities
- Support production of comprehensive business reports, data extracts and tools to improve and maintain CTMS data quality and operations performance utilizing Excel, PowerPoint, graphing and systems skills
- Utilized reports, site nomination and performance metric tool as well as dashboards to assist in managing the quality/compliance of CTMS and TMF
- Initiated study startup of two phase 3 and 4 studies successfully.
Clinical Trials Associate
Allergan Pharmaceutical Corporation
01.2017 - 10.2018
- Planned, prepared, and provided on-site support of investigator meetings as well as distribution of agendas and minutes by collaborating with top team members
- Utilized various applications/systems, including CTMS, IWRS, InForm 6 (EDC) to produce reports aimed at supporting ongoing clinical data reviews
- Streamlined records by organizing and maintaining working files and critical documents
- Supported global trial management for delivery of phase III studies in Central Nervous Systems (CNS) Therapeutic Area and contributed to writing UAT test scripts
- Kept study management reports in SharePoint, while collecting and tracking patient enrollment information and MS Excel trackers to maintain vendor/CRO operations
- Tested specifications and performed edit checks for internal EDC, external IWRS/IVRS systems, and laboratory vendor systems, prepared RFPs and provided supplies and equipment for study sites
- Delivered study related knowledge and materials aimed at supporting regional site managers, while interfacing with IRBs and outside vendors to resolve specific issues
- Key Contributions:
- Gathered and evaluated regulatory/financial documents by collaborating with Study Start-Up Group to attain study activation notice
- Complied with Allergan policy by reconciling and transmitting all essential documentation to CDIC
- Overcome screening subject challenges by boosting subject enrollment at study sites
- Performed extensive data migration of Study data into a new repository in SharePoint.
Clinical Document Associate
Celgene Pharmaceutical Corporation
03.2016 - 01.2017
- Oversaw organizations data, including client information and internal information, while maintaining, backing up, and securing databases
- Submitted data, received and delivered metrics regarding clinical trial documentation as well as monitoring and archiving trial/essential documents
- Initiated study activities by facilitating study managers and clinical research associates, while resolving eTMF queries
- Used spreadsheet to keep track of project deliverables and status
- Key Contribution:
- Utilized LiveLink application to process TMF, eTMF, CRFs and clinical application and file essential documents
- Processed TMF/eTMF documents for global studies and vendor management.
Documentation and Data Specialist
Solix Inc
05.2015 - 10.2015
- Created applications using Siebel database (Oracle) and prepared reports using MS Excel and other MS Office tools
- Ensured data quality meets the standards required for approval of requests and issues are resolved
- Extracted and processed data using SQL
- Processed Schools and Libraries applications for funding and purchasing equipment’s, supplies and funds for Lunch and other programs
- Elance
Remote Editor/Writer
01.2012 - 01.2015
- Performed tasks of reviewing contents from initial through final copy of documents; reviewed final drafts and revision of reports to comply with editorial guidelines; performed content research, content development, management and technical writing
Clinical Regulatory Document Specialist
04.2007 - 12.2010
- Worked closely with Program Physicians, Clinical Trial Managers, and Statisticians
- Ensured compliance of clinical protocols, protocol amendments, clinical study reports, risk management plans and various safety update reports with international registration dossier document standards for electronic publishing
- Managed Quality Control of projects to completion
- Performed Audit of the database system (CREDI) often before outside auditors come in
- Provided end-user training to all team members on the database system and documented control procedures as needed
- Assisted users with technical issues regarding the database system (electronic database management system called CREDI) and periodic testing of the system, version control of reports, electronic filing of documents into CREDI)
- Assisted in the preparation of IND
- IMPDs, CTAs and NDA submission documents and sections of the CTD/eCTD dossiers
- ECTD implementation support for regulatory and clinical documents, prepared for publishing and submission.
Novartis Pharmaceuticals Corporation
09.2001 - 12.2010
Associate Documentation Manager/TMF Associate
09.2001 - 04.2007
- Performed data entry and scanning projects of documents needed in various countries that the Company operated in and for IND/NDA application to Health Authorities around the world
- Filed paper and electronic documentation
- Prepared, scanned and filed Clinical documents
- Worked with Clinical Trial Leaders on set up of eTMF process
- Performed Quality Checks and involved in completing the Study set process, archived paper TMFs
- Processed and assemble boxes with TMF documents for offsite storage
- Tracked documents for archiving
- Notified Iron Mountain Offsite Storage Company when boxes were ready to be archived
- Performed data entry and data verification of all documents
- Participated in training and mentoring new colleagues
- Took part in Study Close Out activities
Education
Master of Science - Clinical Research Administration
Walden University
Minneapolis, MN08.2019
Bachelor of Science - Information Technology and Math
NJ Institute of Technology
Newark, NJ06.2005
Skills
- Technical Skills:
- Microsoft Office Suite Adobe Acrobat/ISI Toolbox Documentum Medidata Rave SAS/SQL Statistics IWRS CTMS EDC InForm ClinAdmin Veeva Vault Technical Editing
Affiliations
SAS and SQL Course, Online Training / 2018
SSRS Reporting Services, SetFocus Institute / 2014
Timeline
Contractor
Seqirus Corporation
09.2021 - 01.2024
contractor
Merck Pharmaceutical Corp
02.2021 - 08.2021
Technical Editor and Copywriter
Inner Metamorposis
04.2020 - 01.2021
Senior Clinical Portfolio Specialist
Novartis Pharmaceuticals Corporation
10.2018 - 10.2019
Clinical Trials Associate
Allergan Pharmaceutical Corporation
01.2017 - 10.2018
Clinical Document Associate
Celgene Pharmaceutical Corporation
03.2016 - 01.2017
Documentation and Data Specialist
Solix Inc
05.2015 - 10.2015
Remote Editor/Writer
01.2012 - 01.2015
Clinical Regulatory Document Specialist
04.2007 - 12.2010
Novartis Pharmaceuticals Corporation
09.2001 - 12.2010
Associate Documentation Manager/TMF Associate
09.2001 - 04.2007
Professional Development
Master of Science - Clinical Research Administration
Walden University
Bachelor of Science - Information Technology and Math
NJ Institute of Technology
Similar Profiles
Mohanad Abdel-RahmanMohanad Abdel-Rahman
Academic Peer Tutor at NAAcademic Peer Tutor at NA
Shlomo JaffeShlomo Jaffe
Highschool Math Tutor at NAHighschool Math Tutor at NA
CLÉLIA CROZE-LABBECLÉLIA CROZE-LABBE
Baby sitter at NABaby sitter at NA
Jaylen Tindale-SeymourJaylen Tindale-Seymour
Property Maintenance at NAProperty Maintenance at NA
Antonio CasasAntonio Casas
Authorization Specialist Assistant Manager at Eye Centers of AmericaAuthorization Specialist Assistant Manager at Eye Centers of America