Mariam Agniel
Draveil
Summary
Results-driven Clinical Research Associate with 6 years of experience overseeing clinical trials. Aiming to transition into a Junior Clinical Trial Manager role to apply expertise in clinical research, trials management, and regulatory compliance for successful project outcomes.
Overview
7
7
years of professional experience
Work History
Senior Clinical Research Associate II
SYNEOS HEALTH
2023.06 - Current
- Oversaw the process of participant enrollment.
- Consistently maintained adherence to research protocols and regulatory standards.
- Collaborated with investigators for efficient trials.
- Conducted pre-study, initiation, and interim visits.
- Managed trial-specific tools and systems.
- Verified drug storage conditions for compliance.
- Inspected electronic data capture systems for integrity.
- Maintained precise records in the trial master file.
- Conducted source document verification, addressed data queries effectively, and rectified discrepancies.
- Monitored and reported safety incidents.
Clinical Research Associate
JANSSEN CILAG- JOHNSON & JOHNSON
2021.06 - 2023.05
- Site Management of Phase II & III Hematology studies Myeloma and AL amyloidosis.
- Performed feasibility assessments, site selection, study initiation, progress monitoring, and managed the closure of study sites.
- Assisted to Study Management Team (SMT) meetings, liaised with the Clinical Research Associates (CRA) team, and scrutinized study-related documents, including budgets and regulatory submissions.
- Assessed the quality and integrity of site practices, escalated issues when necessary, and ensured the implementation of corrective and preventative actions, along with mitigation plans.
- Provided training for CRAs, oversaw study/site metrics at a local level, managed audit visits, prepared for inspections, and conducted mock inspections.
- Kept a close watch on patient recruitment, evaluated potential study risks and opportunities, and managed site-level drug accountability, reconciliation, and disposal tasks. ensured the accuracy and regulatory compliance of Informed Consent forms, tracked study progress through regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Maintained essential documentation such as TMF, ISF, central lab records, newsletters, etc., and guaranteed the availability of current, relevant documentation at investigator sites.
- In collaboration with cross-functional teams, facilitated the timely execution of clinical trials and contributed to process and tool improvement initiatives by leading training workshops as a Subject Matter Expert (SME).
Clinical Research Associate II
DOCS GLOBAL, ICON
2020.05 - 2021.05
- Site Manager outsourced to JANSSEN for Phase II and III Hematology trials.
- Conducted pretrial assessment visits, along with both on-site and off-site monitoring.
- Reviewed Informed Consent Forms (ICF) and data, as well as safety reporting and complaint management.
- Managed the inventory of Investigational Products (IP), ensuring reconciliation and reviewing storage and security measures.
- Assessed the quality and integrity of site practices, escalating any quality issues when necessary.
Clinical Research Associate
EXCELYA
2018.10 - 2020.05
- Outsourced to LYSARC for Phase II and III Hematology (Lymphoma) trials.
- Performed initiation, monitoring visits (including site and pharmacy visits), and close-out visits.
- Conducted clinical monitoring activities and fulfilled the role of an Unblinded Clinical Research Associate (uCRA).
Unité de Recherche Clinique Saint Louis, Assistance publique - Hôpitaux de Paris
2018.01 - 2018.10
- Conducted monitoring and close-out visits.
- Kept proper documentation (Trial Master File, Investigator Site File, central laboratory, newsletters, etc.).
- Provided protocol and related study training to designated sites.
- Managed logistics for various clinical trials.
Education
Clinical Trial Manager certificate -
Leonard De Vinci Institute
France2024-04
Clinical Research Associate certificate -
Leonard de Vinci Institute
France01.2018
PhD Degree in Neuroscience -
Faculty of Sciences, Mohammed V University
Rabat, Morocco2013-04
Skills
- Report Writing
- Documentation Management
- Research experience
- Site Management
- Conflict resolution abilities
- Trial oversight
- Good clinical practice
- Communication
- Teamwork
- Time Management
- Adaptability
- Critical Thinking
Miscellaneous
Native speaker of Arabic, Fluent in French and English, Competence in all MS Office applications, Rave iMedidata, CTMS (iMedidata, Veeva), eTMF (Veeva), SIP, LMS (DrugDev), IRT
References
PUBLICATIONS AND REFERENCES AVAILABLE UPON REQUEST
Timeline
Senior Clinical Research Associate II
SYNEOS HEALTH
2023.06 - Current
Clinical Research Associate
JANSSEN CILAG- JOHNSON & JOHNSON
2021.06 - 2023.05
Clinical Research Associate II
DOCS GLOBAL, ICON
2020.05 - 2021.05
Clinical Research Associate
EXCELYA
2018.10 - 2020.05
Unité de Recherche Clinique Saint Louis, Assistance publique - Hôpitaux de Paris
2018.01 - 2018.10
Clinical Trial Manager certificate -
Leonard De Vinci Institute
Clinical Research Associate certificate -
Leonard de Vinci Institute
PhD Degree in Neuroscience -
Faculty of Sciences, Mohammed V University
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