Rosalind Jones
Manning
Summary
Accomplished Senior Clinical Trial Manager with a proven track record at Novartis Pharmaceutical and Eliassen Group, adept in Clinical Trial Management and cross-functional team leadership. Excelled in ensuring regulatory compliance, enhancing trial efficiency, and managing budgets effectively. Mentored junior staff, fostering professional growth. Demonstrated expertise in vendor management and quality assurance, contributing to successful trial outcomes.
Overview
16
16
years of professional experience
Work History
Senior Clinical Trial Manager
Eliassen Group, Novartis Pharmaceuticals, DOCS Global, NCGS Inc.
08.2016 - 04.2024
- Led multiple clinical trial studies from start-up through close-out, ensuring adherence to regulatory standards and timelines
- Ensured compliance with regulations and maintained study schedules
- Coordinated with cross-functional teams to ensure successful trial outcomes
- Served as the primary operational contact for trial execution
- Managed urgent unblinding activities
- Established and maintained relationships with vendors to ensure timelines, budgets, and quality standards were met
- Monitored trial progress and implemented corrective actions as needed
- Ensured quality control and maintain inspection readiness
- Approved vendor contracts and payments
- Oversaw protocol training activities
- Supported clinical supplies planning
- Assisted with the development of study-related plans
- Conducted risk assessments and managed operational deliverables
- Managed trial budgets and resources effectively
Senior Clinical Research Associate
Avanir Pharmaceutical, Planet Pharma, RPS, Merck Pharmaceutical
12.2007 - 08.2016
- Conducted site selection, initiation, monitoring, and close-out visits
- Managed sites for assigned protocols and ensured appropriate data collection
- Developed and implemented corrective actions as needed
- Generated monitoring visits reports and follow-up letters according to guidelines
- Mediated between sites and internal staff and assisted with protocol and CRF reviews
- Provided mentorship and training to junior Clinical Research Associates, fostering their development, and enhancing team performance
- Served as Lead Clinical Research Associate, providing mentorship to entry level Clinical Research Associates and overseeing clinical trial activities
Education
Master of Business Admin. - Technology Management (Candidate)
Southern University at New Orleans
New Orleans, LASkills
- Clinical Trial Management
- Compliance and regulatory knowledge
- Cross functional team leadership
- Quality Assurance
- Budget management
- Inspection readiness
- Vendor Management
- Training
- Clinical Trials Management and Advanced Operations
- ClinEssentials CTM Training Course
Audit Experience
- Internal SOP/Process Audit
- Investigator Site Audit by CRO, Sponsor, and/or Regulatory Authority
- Audit of CRO by Sponsor and/or Regulatory Authority (includes project-specific audits by a sponsor)
Therapeutic Summary
Immunology, Urticaria (Phases II, III), Infectious Disease/Vaccine, Coronavirus Disease, Respiratory Syncytial Virus (Phase III), Oncology, Acute Myeloid Leukemia (Phase II), Neurology, Migraine (Phases II/III), Infectious Disease, H1N1 Influenza, HIV (Phases II, III), Endocrinology, Diabetes Type 2 (Phase III), Dermatology, Atopic Dermatitis, Roseau (Phases II, III), Cardiovascular, Hypertension, Hypercholesterolemia (Phase III), Oncology, Breast Cancer, Metastatic Colorectal Cancer, Non-Small Cell Lung Cancer (Phases II/III), Neuroscience, Bipolar Disorder, Schizophrenia, Attention Deficit Disorder, Pseudobulbar Affect, Alzheimer's Disease (Phases II, III), Respiratory, Chronic Obstructive Pulmonary Disease (COPD) (Phase III), Ophthalmology, Glaucoma, Diabetic Retinopathy, Macular Degeneration (Phases II, III)
Computer Experience
- MS Office (Word, Excel, PowerPoint)
- CTMS, eTMF (e.g., Veeva Vault)
- Electronic Data Capture (Medidata RAVE/Oracle/Inform)
- Central eDiaries (ePRO, eRT)
- IVRS/IWRS (S-Clinical, ALMAC, Premier IRT, Perceptive, CLIN phone)
Timeline
Senior Clinical Trial Manager
Eliassen Group, Novartis Pharmaceuticals, DOCS Global, NCGS Inc.
08.2016 - 04.2024
Senior Clinical Research Associate
Avanir Pharmaceutical, Planet Pharma, RPS, Merck Pharmaceutical
12.2007 - 08.2016
Master of Business Admin. - Technology Management (Candidate)
Southern University at New Orleans
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