FRANKLINE MBANWI

Albuquerque, USA ***** 513-***-**** ad0n4u@r.postjobfree.com

PROFESSIONAL SUMMARY

Dedicated and results-driven Clinical Trials Project Manager with a proven track record of successfully managing and executing complex clinical trials in a CRO. With a strong background in clinical research associate role, project management, regulatory compliance, and team leadership, I bring valuable expertise to the planning, implementation, and oversight of clinical trials. My comprehensive understanding of the drug development process, coupled with a commitment to patient safety and ethical conduct, ensures the successful completion of trials while meeting all regulatory requirements. I excel in resource allocation, budget management, risk mitigation, and data integrity, which are critical components in the execution of clinical research. My exceptional communication skills foster collaboration among cross-functional teams, investigators, and stakeholders, resulting in streamlined processes and on-time delivery of trial outcomes. As a Clinical Trials Project Manager, I am poised to contribute to the advancement of medical science and the development of innovative treatments, while maintaining the highest standards of quality and compliance. SKILLS

• MS Office-Word

• Excel

• PowerPoint

• Project

• Skype for Business

• Outlook

• OneNote

• MS Teams

• CTMS (Veeva, Impact Harmony, E-Clinical,

SimpleCTMS, Eshare)

• EDC (IBM Clinical, Zelta, Veeva EDC, Medidata

RAVE, InForm, TrailMaster file, iMednet)

• Electronic Trail Master (Veeva-Vault Clincal)

• Image Management System (AG Mednet) Amber

Health

• IVRS (ClinPhone)

• Risk Management

• Project Management

• Project Planning

• Compliance Monitoring

• Document Management

• Root Cause Analysis

• Project Tracking

• Performance Improvements

• Cross-Functional Collaboration

• Expense Reports

• EMR systems( EPIC, Sunrise etc)

• Drug accountability system(Vestigo)

WORK HISTORY

Clinical Trial Project Manager,

Carelon Research – NM

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

• Collect data and follow research protocols, operations manuals, and case report form requirements.

• Followed informed consent processes and maintained records.

• Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

• Maintained compliance with protocols covering patient care and clinical trial operations.

• Monitored unit budget to meet financial objectives for spend rate and funding.

• Skilled at working independently and collaboratively in a team environment.

• Self-motivated, with a strong sense of personal responsibility.

• Proven ability to learn quickly and adapt to new situations.

• Worked well in a team setting, providing support and guidance.

• Worked effectively in fast-paced environments.

• Managed time efficiently in order to complete all tasks within deadlines.

• Demonstrated respect, friendliness and willingness to help wherever needed.

• Excellent communication skills, both verbal and written.

• Passionate about learning and committed to continual improvement.

• Proved successful working within tight deadlines and a fast-paced environment.

• Worked flexible hours across night, weekend and holiday shifts.

• Participated in team projects, demonstrating an ability to work collaboratively and effectively.

• Cultivated interpersonal skills by building positive relationships with others. Clinical Research Associate Sr-CLR, 09/2021 - Current Carelon Research, Inc.

• Complete routine on-site/remote monitoring according to SOPs and complete reports to quality standards within company specified timelines

• Complete both remote and onsite drug accountability/ reconciliation for assigned clinical sites

• Responsible for all tasks related to the monitoring and management of clinical trials for assigned sites

• Monitor Phase I-IV clinical trials, assuring adherence to Good Clinical Practices

• Prepares, collaborates and implements Corrective Action Plans with investigative sites

• Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Carelon Research SOPs

• Collaborates with the Lead CRA(s) /In-house CRA(s) to obtain/share trial specific issues across all study sites concentrating on areas related to quality, site performance and metrics

• Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and In-house CRAs as appropriate

• Complete follow up letters for all visits according to SOPs and complete reports to quality standards within company specified timelines

• Develops and maintains collaborative working relationships with clinical investigative sites

• Trials: Phase II-IV, Pain Management (Rheumatoid Arthritis), Cardiovascular Diseases

(Myocarditis/Pericarditis), Obesity, COVID-19 Vaccines

• Number of sites, 17

• Regional Travel

• Up to 80 percent travel.

Clinical Research Associate II, 08/2019 - 08/2021

BioMarin Pharmaceutical Inc.

• Complete site selection, site initiation and routine on-site /remote monitoring and close-out visits according to SOPs and complete reports to quality standards within company specified timelines

• Responsible for all tasks related to the monitoring and management of clinical trials for assigned sites

• Monitor Phase II-IV clinical trials, assuring adherence to Good Clinical Practices

• Prepares, collaborates and implements Corrective Action Plans with investigative sites

• Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and BioMarin SOPs

• Attends Investigator Meetings and study-specific training for assigned trials

• Collaborates with the Lead CRA(s) to obtain/share trial specific issues across all study sites concentrating on areas related to quality, site performance and metrics

• Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and CRAs as appropriate

• Complete follow up letters for all visit types according to SOPs and complete reports to quality standards within company specified timelines

• Develops and maintains collaborative working relationships with clinical investigative sites

• Accountable for data integrity, patient safety and regulatory compliance for all assigned sites

• Monitor's recruitment and data quality while on site and remotely through EDC systems/communication with sites

• Performs on-site/remote drug accountability and reconciliation

• Verify drug storage and ensure that drug handling meets protocol and SOP requirements

• Responsible for maintaining current Investigator Site File (ISF) in accordance with BioMarin SOPs

• Performs ongoing reviews of ISF to assure quality of the documentation files and compliance with BioMarin SOPs, GCP and ICH Guidelines while on site

• Responsible for assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan

• Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites

• Assists the project team in preparation for audits/inspections readiness, responsible for the quality and completeness of site related performance and documentation

• Trials: Phase II, III and IV

• Infectious Disease (HIV, Hepatitis C), Respiratory (Cystic Fibrosis), Cardiovascular (Hypertension), Pain Management (Headache Migraine, Rheumatoid Arthritis)

• Number of sites, 14

• Regional Travel

• Up to 70 percent travel.

Clinical Research Associate I, 10/2017 - 08/2019

AbbVie Pharmaceuticals

• Perform and coordinate all aspects of the clinical monitoring process in compliance with ICH/GCP guidelines and other regulatory agency guidelines

• Conduct site visits to determine protocol and regulatory compliance and prepare required documentation

• Ensure that the data reported in site source documents is accurate, complete and verifiable

• Perform drug accountability at site visits to ensure proper preparation, handling, dosing and storage of drugs

• Review investigational trial files to ensure completeness and retrieve documents as appropriate for the sponsor's trial master file

• Maintain ongoing and continuous professional communication with the clinical site and the study team throughout the duration of the study

• Assist with site selection as directed by team members

• Trials: Phase II-III Pain Management (Pain – Chronic Pain, Back, Rheumatoid Arthritis), CNS, (Epilepsy, Bipolar disorder)

• Number of sites, 10

• Nationwide travel

• Up to 65 percent travel.

Research Assistant, 12/2012 - 04/2017

Institute of Agricultural Research for Development (IRAD)

• Perform routine lab work and some PCR Reactions

• DNA extraction from whole blood and L3s of Ochocerca ochengi, faecal examination for helminthes eggs, blood centrifugations and Buffy coat examination for trypanosomes

• Feeding and dissection of Simulium flies

• Obtain their excretory-secretory products and later capture the proteins into protein beads

• Tse-tse flies capture, identification, preservation, and dissection and as well using molecular techniques to screen for trypanosomes.

EDUCATION

Master of Science: Biochemistry And Molecular Biology, 11/2012 University of Buea - Cameroon

Bachelor of Science: Medical Laboratory Technology, 11/2010 University of Buea - Cameroon

CERTIFICATIONS

• University of Delaware, 09/2023

• Clinical trial project management certificate

• ICH/GCP Certification, 09/2021

• Clinical Research Training, 06/2016

• ICH/GCP Training

LANGUAGES

French (fluent)

English

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