Ann Cleona
Clinical Scientific Expert
Manchester,MAN
Summary
With a decade of extensive experience in the clinical industry, I bring a wealth of knowledge and expertise in Clinical Data Review, patient safety, and Drug Development. Throughout my career, I have specialized in Oncology, Haematology, Paediatrics, Cardiology, and immunology studies in various Clinical roles, supported by four years as a medical officer. My proficiency in these areas is further reinforced by a master's degree in Drug Discovery and Development. As a proactive and self-assured professional, I am driven to exceed company expectations and currently seeking a position in the health sector that offers promising prospects and avenues for career growth. I sincerely appreciate your consideration of my application.
Overview
9
9
years of professional experience
8
8
years of post-secondary education
Work History
Clinical Scientific Expert
NOVARTIS
United Kingdom
12.2022 - Current
- Performed high quality clinical data review and identified clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database lock and Post Lock activities and facilitated resolution of clinical data issues on 4 or more projects at a time
- Supported in the development and amendment of protocols.
- Involved in tasks related to updating the Investigation Brochure, contributing to various aspects of its development and maintenance.
- Collaborated with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
- Identified any instances of protocol deviations.Subsequently, I meticulously documented these deviations in the database, ensuring the maintenance of accurate and consistent data throughout the study.
- Contributed to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
- Supporting pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)).
- Worked towards developing subject matter expertise (disease area knowledge (Oncology and Hematology).
Senior CDC
Primera Medical Technologies
India
10.2018 - 10.2021
- Examined draft protocols, located forms, and assisted the designer in carrying out their designing tasks
- Developed a data management strategy, data import and transfer agreements, etc
- Raising queries of discrepant documentation and updating the changes within the patients’ records
- Made CRF completion guidelines using the CRFs that had been annotated.
- Edit check and Screen UAT were performed.
- QC TMF document indexing and archiving for internal studies.
- Performed SAE reconciliation of clinical database against safety database.
- Review and document evidence of compliant and non-compliant documents
- Conducted SAE reconciliation and worked on lab reconciliations, including local and central laboratories, for effective data validation that produced consistentency.
- Assured the regular clinical data and data structure were accurate, full, and consistent.
- Completed study closure tasks, such as data review, data freezing, and study lock.
- Reviewed the research protocol and helped site coordinators, investigators, and field clinical personnel gather necessary data to quickly fulfil the protocol's requirements.
- Add the results of the UAT to the Communication log and keep track of the Database development team & being able to manage several projects with quickly shifting deadlines and priorities.
Medical Officer
Aster Prime hospitals
India
04.2015 - 01.2018
- Overseeing the outpatient department of Cardiology in a bustling hospital
- Interpreting diagnostic investigations such as ECG, ECHO, TMT, TEE tests and assisting with Cath-lab procedures.
- Translated patient information into databases with complete accuracy
- Scheduled appointments, conducted examinations, and facilitated investigations
- Monitored vital signs, managed admissions and discharges, and documented clinical trial data
- Provided pre- and post-procedure counselling to patients
- Interpreted lab results and referred patients for further evaluation.
- Monitored medication compliance and adjusted doses when necessary
- Assisted during coronary interventions and managed the department in staff absence.
Education
Masters in Drug Discovery and Development - undefined
09.2020 - 05.2022
- Thesis Title: In vitro simulation of patient breathing profiles
- Research Development
- Drug development and discovery
- Quality assurance, clinical trials, Regulatory affairs, and analytical instrumentation
- Fundamentals of formulation drug delivery and biopharmaceutics
- Nanomedicine and biotechnology products
- Research project
MBBS (Bachelor’s in medicine and bachelor’s in surgery) - undefined
01.2008 - 04.2014
Subjects: Anatomy, Physiology, Biochemistry, Pharmacology, Pathology, Microbiology, Internal Medicine, Surgery, Obstetrics and Gynaecology, Ophthalmology, Dermatology, Forensic Medicine, Orthopaedics’, Anaesthesia, Paediatrics, ENT, Psychiatry, Radiology
Science Education
- Botany
- Chemistry
- Physics
- Zoology
Skills
Clinical Data Review
Clinical Data Trends Analysis
Protocol Development
Investigation Brochure Updating
Data Quality Plan (DQP) Implementation
Pharmacovigilance Support
Medical/Scientific Writing
Disease Area Expertise (Oncology, Hematology)
Good Clinical Practice (GCP)
Analytical and Computational Skills
SAE reconciliation
Good communication skills
Medical terminology
Self-motivation, discipline, and willingness to learn
Clear verbal and written communication skills
Excellent time management skills
Ability to work well under pressure and remain effective
Ability to multitask in an organised manner
Good analytical skills, and able to work methodically and accurately
Dataanalyticaltools
- TIBCO
- Spotfire
- Qlik sense
- Excel
Edctools
- Medidata Rave
- Clinical Oracle
- Inform
- CREDI
- Subway
- J review
- Veeva Vault
Timeline
Clinical Scientific Expert - NOVARTIS
12.2022 - Current
University of Central Lancashire - Masters in Drug Discovery and Development,
09.2020 - 05.2022
Senior CDC - Primera Medical Technologies
10.2018 - 10.2021
Medical Officer - Aster Prime hospitals
04.2015 - 01.2018
Southeast University - MBBS (Bachelor’s in medicine and bachelor’s in surgery),
01.2008 - 04.2014
Sri Chaitanya Junior College - , Science Education