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.

EMPLOYMENT ALPHA BIORESEARCH

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

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

Study type

Study Focus

Start date

(MMM/YYYY)

Finish date (MMMM/YYY Y)Medical DevicesIntra-cardiac

Devices (x4 studies)

Phase IVDevicesMay/2019Aug/2021Pediatric studiesNEC Prevention in neonate

Phase IIIDrugMay/2019July/2021DermatologyPenphigusPhase IIIDrugDec/2019Aug/2021OncologyT-Cell therapyPhase IIDrugMay/2019May/2021OncologyBreast CancerPhase IIIDrugJune/2017April/2019DermatologyPsoriatic ArthritisPhase IIIDrugOct/2018Apr/2019Medical DevicesDialysis (ICU)Phase IIIDrugJan/2018March/2018OncologySolid TumorsPhase IDrugMarch/2018Sep/2018OncologyCAR-TPhase IICell therapyApr/2016Apr/2017OncologyProstatic CancerPhase IIIDrugApr/2016Apr/2017Rare DiseaseLALDPhase IIIDrugApr/2015Apr/2017OphthalmologyRetinitis

Pigmentaria (adRP)

Phase IIIDrugJan/2017Apr/2017OphthalmologyMacular EdemaPhase IIIDrugJan/2015Jun/2016Rare DiseaseSan PhillipoPhase IIIGene therapyJan/2015Apr/2016OphthalmologyUveitisPhase IIIDrugOct/2014Feb/2014CardiovascularThromboembolismPhase IIIDrugJun/2006Jun/2008Pediatric studiesRSV Vaccinein neonate

Phase IDrugJun/2004Jun/2006Infectious disease

AIDSPhase IVDrugJan/2003Jun/2004InfectiousdiseaseFungal Infections in transplantPhase IIIbDrugJan/2003Jun/2004CNS, Mental disorders

MS, Early RRMS

Surveillance Trial

Phase IIIDrugJan/2002Jun/2004CNS, Mental disorders

DepressionPhase IVDrugJan/2002Jun/2004CNS, Mental disordersMigrainePhase IVDrugJan/2002Jun/2004GastrointestinalReflux (GERD)Phase IIIDrugJan/2003Jun/2004RespiratoryCOPDPhase IIIDrugJan/2003Jun/2004HepathologyLiver TransplantPhase IIIDrugJan/2003Jun/2004

EDUCATION

Year: 1998.- BS in Pharmacy, Complutense University in Madrid

MASTER, COURSES

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

Clinical trials platforms: IWRS, CASCADE, CTMS, and Remarque.

LANGUAGES

LANGUAGE

UNDERSTANDINGSPEAKINGWRITINGLISTENINGREADINGSPOKEN

INTERACTION

SPOKEN

PRODUCTION

EnglishC1.1C1.1C1.1C1.1C1.1

EDUCATION

Year: 1998.- BS in Pharmacy, Complutense University in Madrid

MASTER, COURSES

Master’s in clinical Trial Monitoring, Pharmacist Collegeof Madrid

• Monitoring Clinical Trials and Clinical Research
• ICH/GCP and regulatory environment