Jeremy Rogers
London
Summary
Professional Statement
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Knowledgeable Global Clinical Trial Manager and adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues.
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Joined Roche/Genentech to contribute specialist biomarker expertise to the early-phase Oncology portfolio. Arrived at the EU headquarters of Gilead Science during the height of the SARS-nCoV2 outbreak. Taking up new challenges and working with international partners. Gaining extensive expertise in commercial research and applying my talents to dynamic initiatives.
With expertise in non-interventional/interventional research at a global biotechnology company, such as Roche and Gilead. Having worked for a Contract Research Organization (CRO) and residing in Mainland China, I can provide a unique viewpoint on APAC/EU/North American drug development.
Overview
2
2
years of professional experience
Work History
Clinical Research Manager
IPSEN Biopharma
Paris, France
01.2023 - 07.2023
- Therapeutic Areas; Oncology / Rare Disease
- Phases; II / III
- Global Responsibility / Vendor Management / Managing Cross-functional Teams / Line Management Responsibility
- Project Managed 2 Global Sponsored study, for final approval from the CHMP-EMA and the FDA
- I engaged with cross-functional teams to oversee and streamline clinical trial processes, ensuring that all projects were executed effectively and in compliance with industry regulations – ahead of regulatory review.
- 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.
- Skilled at working independently and collaboratively in a team environment.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Followed informed consent processes and maintained records.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Clinical Operations – Biomarker Operations Project Manager / Clinical Operations Lead
Roche/Genentech
Welwyn Garden City, UK
12.2021 - 09.2022
- Identified opportunities to improve clinical practices, devised strategies and implemented plans to increase patient care standards and enhance operational procedures.
- Communicated effectively with staff members, physicians, and patients, employing active listening and interpersonal skills.
- Promoted high morale and staff retention through dynamic communication, prompt problem resolution, proactive supervisory practices and facilitation of positive work environment.
- Delivered effective onboarding and training to new and existing employees and cross-trained staff members in other job roles to maximize coverage.
- Delegated tasks to staff members, monitored completion of all duties and provided support to enhance performance.
- Handled job duties for staff members which were unavailable or out of office.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Education
Biochemistry
University of Central Lancashire
Preston, UK07.2013
Chinese Language And Literature
Harbin Engineering University
Harbin, Heilongjiang, China07.2019
Skills
PROJECT MANAGEMENT EXPERIENCE
- Compliance Review / Trial Management /Protocol Development
- Statistical Analysis / Budget Control / Documentation Requirements
- Good Clinical Practices / Informed Consent / Clinical Trial Expertise
- Clinical Trial Setup – Early Phase Application and Approval
- Legal and Regulation Coordination (Protocol Amendments, Change in methodology etc)
- Business Development, Quality Control, Management
PRACTICAL SKILLS
- Operating Systems Microsoft Windows 11, MacOS and Open Source Linx
- MS Office; Word, Excel, Powerpoint, OneNote, Database and Project Manager / GSuite
- Veeva Vault (eTMF), iMedidata (RAVE), Winpath, Qpulse, APEX/CoPath (medical software)
- SOP (Standard Operating Procedure) Writing/Editing
- Analsyers – autolab, dako, G8 Tosoh Hba1c (chromatography), Roche Cobas
- Biochemistry/Microbiology/Histology and Genetics Laboratory Experience
- Patient Handling / Staff Training
- Independent Monitoring Experience (Two years) / Laboratory Experience (Seven years)
- CDx(Clinical Diagnostic)/Trial Sample Handling, pathology specimens, HIV, Oncology Trials
CERTIFICATES & MEMBERSHIPS
- GCP - Good Clinical Practice (MHRA Certified & ICP–For Clinical Trials)
- GCLP - - Good Clinical Laboratory Practice (MHRA Certified)
- Human Tissue Act Certificate (MHRA Certified)
- CSTF Mandatory and Practical Training (NHS and CPD Accredited)
Accomplishments
- Therapeutic Areas; Oncology / Infectious disease / Ophthalmology / Neurodegenerative disease (I2ON) / COVID-19 / HIV / NASH / HCV / HBV / Rare Disease
- Phases; 1b / II / III / IV Real World Evidence (RWE)
- Global Responsibility / Vendor Management / Managing Cross-functional Teams
- Management Experience (including central and external laboratory setup)
- Project Managing Global Sponsored and Investigator Sponsored Studies, in various project development
- Participating in two global priority studies in NA/EU and APAC
- With involvement with the FDA (USA), EMA(EU) and HGRAC (China) for product development
- Independent Monitoring ongoing studies and sites
- Central Laboratory Project Management Experience
- GCLP and GCP Experience
- Used Microsoft Excel to develop inventory tracking spreadsheets.
Languages
English
Native language
Chinese (Mandarin)
Advanced
C1
Timeline
Clinical Research Manager
IPSEN Biopharma
01.2023 - 07.2023
Clinical Operations – Biomarker Operations Project Manager / Clinical Operations Lead
Roche/Genentech
12.2021 - 09.2022
Biochemistry
University of Central Lancashire
Chinese Language And Literature
Harbin Engineering University