Epoupa Hatman
Bologna
Summary
I have strong data entry experience and willing to contribute to the company growth
Overview
13
13
years of professional experience
1
1
Certification
Work History
Senior Data Entry Support/Data Entry Verification
WCT
01.2021 - Current
- Support clinical data entry from source document to validated system
- Verify and validate clinical data accuracy
Senior Data Entry Support/Data Entry Verification
PRA Health Science
06.2020 - 01.2021
- Support clinical data entry from source document to validated system
- Verify and validate clinical data accuracy
Senior Data Entry Support/Data Entry Verification
Clintec International
11.2018 - 06.2020
- Support clinical data entry from source document to validated system
- Verify and validate clinical data accuracy
Senior Clinical Research Associate
IQVIA
08.2013 - 11.2018
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, trains site staff on the proper conduct of clinical trials
- Monitors the progress of clinical trials at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements
- Closes clinical trials at investigative sites
- Ensures sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- Performs source document verification and query resolution
- Completes monitoring activity documents as required by IQVIA/sponsor’s SOPs or other contractual obligations
- Performs essential document site file reconciliation
- Verifies Serious Adverse Event (SAE) reporting
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Updates all applicable tracking systems
- Communicates with investigative sites
- Provides regular site status information to team members, trial management, and updates trial management tools
- Escalates site and trial related issues; works closely with other clinical team members and follows up until identified issues are resolved or closed
- Ensures all required training is completed and documented
- Facilitates audits and audit resolution
Local Study Manager
GLAXOSMITHKLINE
03.2012 - 03.2013
- Projects Management (from Study Initiation to Study close-out)
- Proactively manage project level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors
- Provide efficient updates on trial progress to the Head of Clinical Operations (DCO), with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation
- Perform study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements
- Ensure potential study risks are escalated to the attention of the Head of Clinical Operations when appropriate
Trainee (Local Study Manager)
GLAXOSMITHKLINE
09.2011 - 03.2012
- Support Local Study Manager with all task related to the study management
Education
Postmaster Degree - Marketing, Market access and Sales
ISTUM
Florence, Toscana07.2018
Postmaster Degree - Pharmacovigilance and Drug
University of Verona
Verona, Veneto07.2011
5 years master’s degree - biology
University of Bologna
Bologna, Emilia Romagna03.2011
Skills
- Oncology
- CNS/Neurology/Psychiatry
- Alzheimer disease
- Schizophrenia
- Parkinson
- Polio
- Cardiovascular
- Coronary Syndrome
- Gastroenterology
- Chronic Ulcerative colitis
- Crohn’s disease
- Respiratory
- Chronic obstructive pulmonary disease
- Endocrinology
- Diabetes
- Post Covid-19
- Rare Diseases
- Niemann-Pick disease Type C
- IVRS
- ECRF
- ACM lab
- Covance lab
- MIAC
- ERT
- CLINPHONE
- QUINTILES ECG
- LAB
- BRT
- Bioclinica
- Foundation Medicine
- Resolution Bio
- Oracle-Inform
- EPRO
- EPharmaSolution
- Lablink
- Preclarus laboratory
- Calyx portal
- Cerba portal
- IBM Clinical
Professionalmemberships
Italy Assomonitor Organization, 2020
Certification
- Certified Clinical Research Associate (CCRA), PRA Health Sciences, 01/01/21, Italy
- Certified Clinical Research Associate (CCRA), Clintec International, 11/01/18, Italy
- Certified Clinical Research Associate (CCRA), IQVIA, 08/01/13, Italy
Businessaddress
Via Giorgio Ribotta 21, Rome, Lazio, 00144, Italy
Languages
French
Italian
English
Updated
12/10/24
Expertise
From I to IV, Solid and liquid tumors (7 years and 6 years of experience), Alzheimer disease (more than 5 years of experience), Schizophrenia (2 years of experience), Parkinson (6 years of experience) and Polio (2 years of experience), Coronary Syndrome (3 years of experience), Chronic Ulcerative colitis and Crohn’s disease (1 year of experience), Chronic obstructive pulmonary disease (1 year and 6 months of experience), Diabetes (4 years of experience), 1 year and 6 months, Niemann-Pick disease Type C, 2 years of experience, IVRS (Datatrack, Suvoda, Almac, IXRS), eCRF (Medidata Rave, Datatrack, Inform, IBM OCRDC), ACM lab, Covance lab, MIAC, ERT, CLINPHONE, QUINTILES ECG and LAB (Q2 Solution), BRT, Bioclinica, Foundation Medicine, Resolution Bio, Oracle-Inform, EPRO, ePharmaSolution, Lablink, ACM laboratory, Preclarus laboratory, Calyx portal, Cerba portal, IBM Clinical
Affiliations
- Membership of Italy Assomonitor Organization
Timeline
Senior Data Entry Support/Data Entry Verification
WCT
01.2021 - Current
Senior Data Entry Support/Data Entry Verification
PRA Health Science
06.2020 - 01.2021
Senior Data Entry Support/Data Entry Verification
Clintec International
11.2018 - 06.2020
Senior Clinical Research Associate
IQVIA
08.2013 - 11.2018
Local Study Manager
GLAXOSMITHKLINE
03.2012 - 03.2013
Trainee (Local Study Manager)
GLAXOSMITHKLINE
09.2011 - 03.2012
Postmaster Degree - Pharmacovigilance and Drug
University of Verona
5 years master’s degree - biology
University of Bologna
Postmaster Degree - Marketing, Market access and Sales
ISTUM
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