Acerca de Marcial Anegón:
Leads, manages and actively monitors/oversee the clinical monitoring team with a focus on quality and timely deliverables; addressing any issues with the appropriate team member and their line manage. Works cross functionally with PM, Data Managers (DM), Clinical Monitoring Services team (CMS) to deliver project deliverables.
Experiencia
EMPLOYMENT ALPHA BIORESEARCH
Head of Clinical Operations October, 2022 – present
Globally,HoC must manage all clinicaltrials, observational studiesand research projectscarried out in AlphaBioresearch, therefore supervising the work carriedout by the personnel involvedin them. Ensure compliance with the established deadlines, the quality, customer requirements and the budgetdefined for each project(MSA).
It is therefore a multidisciplinary position in which the Head of Clinical must know, plan, supervise and evaluate the development of the projects carried out in Alpha Bioresearch reporting to CEO. Financial acumen and budget management experience, 3 years. Experience with CROs, other clinical vendors, and outsourced operations, 3 years.
PREVIOUS PROFESSIONAL EXPERIENCE
Premier Research Madrid
Clinical Lead-
Leads, manages and actively monitors/oversee the clinical monitoring team with a focus on quality and timely deliverables; addressing any issues with the appropriate team member and their line manage. Works cross functionally with PM, Data Managers (DM), Clinical Monitoring Services team (CMS) to deliver project deliverables.
10 years of oncology-related work experience. Previous experience performing oncology clinical research studies, 5 years. Project/trial management experience, 3 years.
Aug 2021 – Sep 2022
Premier Research Madrid
Senior Clinical Research Associate May 2019 – Aug 2021
PRA, (Pharmaceutical Research Associate Spain) Oct 2018 – Apr 2019
Senior Clinical ResearchAssociate
IQVIA
March 2018 – Sep 2018
Senior ClinicalResearch Associate
FAKKEL (Devices)
Jan 2018 – March 2018
Freelance Senior ClinicalResearch Associate
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama) June 2017 – Dec 2017
Senior ClinicalResearch Associate
PPD (Pharmaceutical Product Development) Jun 2004 – Apr 2017
Senior (Lead) Clinical Research Associate
Covance (ex-Chiltern)
Jan 2002 – Jun 2004
Clinical ResearchAssociate
THERAPEUTIC EXPERIENCE
| Therapeutic Area |
Indication |
Study type |
Study Focus | Start date (MMM/YYYY) | Finish date (MMMM/YYY Y) |
| Medical Devices | Intra-cardiac Devices (x4 studies) | Phase IV | Devices | May/2019 | Aug/2021 |
| Pediatric studies | NEC Prevention in neonate | Phase III | Drug | May/2019 | July/2021 |
| Dermatology | Penphigus | Phase III | Drug | Dec/2019 | Aug/2021 |
| Oncology | T-Cell therapy | Phase II | Drug | May/2019 | May/2021 |
| Oncology | Breast Cancer | Phase III | Drug | June/2017 | April/2019 |
| Dermatology | Psoriatic Arthritis | Phase III | Drug | Oct/2018 | Apr/2019 |
| Medical Devices | Dialysis (ICU) | Phase III | Drug | Jan/2018 | March/2018 |
| Oncology | Solid Tumors | Phase I | Drug | March/2018 | Sep/2018 |
| Oncology | CAR-T | Phase II | Cell therapy | Apr/2016 | Apr/2017 |
| Oncology | Prostatic Cancer | Phase III | Drug | Apr/2016 | Apr/2017 |
| Rare Disease | LALD | Phase III | Drug | Apr/2015 | Apr/2017 |
| Ophthalmology | Retinitis Pigmentaria (adRP) | Phase III | Drug | Jan/2017 | Apr/2017 |
| Ophthalmology | Macular Edema | Phase III | Drug | Jan/2015 | Jun/2016 |
| Rare Disease | San Phillipo | Phase III | Gene therapy | Jan/2015 | Apr/2016 |
| Ophthalmology | Uveitis | Phase III | Drug | Oct/2014 | Feb/2014 |
| Cardiovascular | Thromboembolism | Phase III | Drug | Jun/2006 | Jun/2008 |
| Pediatric studies | RSV Vaccinein neonate | Phase I | Drug | Jun/2004 | Jun/2006 |
Infectious disease | AIDS | Phase IV | Drug | Jan/2003 | Jun/2004 |
| Infectiousdisease | Fungal Infections in transplant | Phase IIIb | Drug | Jan/2003 | Jun/2004 |
CNS, Mental disorders | MS, Early RRMS Surveillance Trial | Phase III | Drug | Jan/2002 | Jun/2004 |
CNS, Mental disorders | Depression | Phase IV | Drug | Jan/2002 | Jun/2004 |
| CNS, Mental disorders | Migraine | Phase IV | Drug | Jan/2002 | Jun/2004 |
| Gastrointestinal | Reflux (GERD) | Phase III | Drug | Jan/2003 | Jun/2004 |
| Respiratory | COPD | Phase III | Drug | Jan/2003 | Jun/2004 |
| Hepathology | Liver Transplant | Phase III | Drug | Jan/2003 | Jun/2004 |
EDUCATION
Year: 1998.- BS in Pharmacy, Complutense University in Madrid
MASTER, COURSES
Year: 2001
Master’s in clinical Trial Monitoring, Pharmacist Collegeof Madrid
- Monitoring Clinical Trials and Clinical Research
- ICH/GCP and regulatory environment
OTHER PROFESSIONAL OR SPECIALIST TRAINING
Computing: AdvancedLevel of Office Package, advancedweb browsing, windowsoperating system, ImageJ, GraphPad Prism, introduction to R.
Clinical trials platforms: IWRS, CASCADE, CTMS, and Remarque.
LANGUAGES
MOTHER TONGUE(S): Spanish
LANGUAGE | UNDERSTANDING | SPEAKING | WRITING | ||
| LISTENING | READING | SPOKEN INTERACTION | SPOKEN PRODUCTION | ||
| English | C1.1 | C1.1 | C1.1 | C1.1 | C1.1 |
Educación
EDUCATION
Year: 1998.- BS in Pharmacy, Complutense University in Madrid
MASTER, COURSES
Year: 2001
Master’s in clinical Trial Monitoring, Pharmacist Collegeof Madrid
- Monitoring Clinical Trials and Clinical Research
- ICH/GCP and regulatory environment
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