Silvia Centenera
Summary
Over twenty-five (25+) years of clinical research experience, of which four (4) in a Pharma company and over twenty (20+) in different CROs. Extensive global team management and operational knowledge gained through several years holding leadership roles within project management and clinical operations. Highly independent in taking decisions and, at the same time, able to interact cross-functionally, as required within a matrix environment. Very much results oriented, skilled in applying critical thinking and creative approaches to risk management and problem solving. Therapeutic experience in Oncology and Hematology, Rare Diseases, Nephrology, Infectious Diseases, Respiratory, Traumatology and Rheumatology. For the last few years, particularly focused on Early Phase clinical trials, as well as the clinical development of innovative biologicals, including monoclonal antibodies, gene and cell therapy.
Strategic Senior Director known for high productivity and efficient task completion. Specialize in leadership development, operational strategy, and financial acumen. Excel in communication, problem-solving, and adaptability, ensuring seamless project execution and team synergy.
Overview
30
30
years of professional experience
Work History
Senior Director of Portfolio Management
Bionical Emas
Odemira
02.2024 - Current
- Accountable for client-specific portfolio management
- Oversees project delivery operations for key accounts and partnerships
- Provides business development assistance to achieve target revenue and profitability
- Ensures the contracted services and expectations for all projects are delivered by the project teams in accordance with executed contracts and Sponsors’ expectations
- Provides oversight for all assigned projects to ensure study launch, conduct and closeout occur according to the sponsor’s and company's contractual agreement
- Ensures studies progress according to internal and Sponsor quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations.
Head of Clinical Operations
Bionical Emas
Odemira
04.2023 - 02.2024
- Leads the Clinical operations Department, which involves Project Management, Clinical Team management and Clinical Monitoring
- Assists in the development and maintenance of a profitable clinical operations group
- Supports with oversight of studies and management of existing clients
- Collaborates with commercial and business development with new clients and opportunities, including participating in the creation and review of new proposals and budgets and attending bid defence meetings where appropriate
- Supports developing training programmes in conjunction Clinical Development management
- Responsible for the creation, maintenance and implementation of Clinical Operations SOPs and processes
- Oversees the management of allocated clinical projects assigned to Clinical Operations Teams to ensure projects are managed and delivered to time, quality, and profit
- Line management of Clinical Operations staff.
Head of Compliance and Clinical Monitoring
Bionical Emas
Odemira
09.2022 - 04.2023
- Supports Clinical Development with the coordination and management of clinical operations activities
- Assists in the development and maintenance of a profitable clinical operations group
- Supports with oversight of studies and management of existing clients
- Collaborates with commercial and business development with new clients and opportunities, including participating in the creation and review of new proposals and budgets and attending bid defence meetings where appropriate
- Supports developing training programmes in conjunction Clinical Development management
- Responsible for the creation, maintenance and implementation of Clinical Operations SOPs and processes
- Oversees the management of allocated clinical projects assigned to Clinical Operations Teams to ensure projects are managed and delivered to time, quality, and profit
- Line management of Clinical Research Associates and other staff as applicable.
Senior Director, Oncology, Global Project Delivery
LabCorp (previously Covance Inc.)
Madrid
03.2021 - 05.2022
- Oversees and leads operational, financial and quality delivery of a portfolio of clinical studies conducted within Oncology therapeutic area, encompassing consistent quality while mitigating risk and assuring patient safety, data integrity and GCP compliance
- Serves as the voice of the client, supporting their expectations and satisfaction, ensuring effective project design and execution while fostering strategic relationships
- Acts as an escalation point for the client over the core project team and helps them to navigate within the company to get to the right solutions as required
- Supports the development and implementation of consistent project tools, templates and reports that deliver informative performance metrics and other critical information to stakeholders
- Responsible for the line management and talent development of assigned project management staff
- Ownership of the global P&L for the Oncology department, including top line growth, operating margin, project cost variance, forecasting, change order management, expense management, and other business metrics
- Contributes to business development strategies and proposals
- Aligns and supports Oncology department strategy, initiatives and focus in line with Global Project Delivery (GPD) and Clinical Development Commercialization Services (CDCS) strategy.
Vice President, Project Management EU
Clinipace Clinical Research
Madrid
01.2020 - 01.2021
- Responsible for the strategic development and oversight management of the Project Management Department
- Ensures the delivery of the projects led by the Project Managers and Directors, within the agreed timelines and budget, and strictly following regulations and the procedures defined in the SOPs and study plans to ensure the highest quality standards
- Oversight and leadership for the operational delivery of twenty-three (23) projects in the department, most of them global, in different indications, including oncology, rare disease, infectious diseases and respiratory
- Accountable for the global growth of the Project Management Department, including the setup of the departmental goals in alignment with the corporate ones
- Development of project management SOPs, processes, and tools
- Development of departmental and study specify KPIs and metrics
- Line management and departmental oversight responsibility
- Works in cooperation with the other departmental heads, to ensure smooth cross-functional interactions, leading to successful fulfillment of corporate goals and objectives
- Contributes to business development activities to assess project feasibility, develop proposals, define requirements and budgets, and assist with project bid defenses.
Director, Project Management
Clinipace Clinical Research
Madrid
09.2018 - 01.2020
- Responsible for the development and management of projects and programs, ensuring oversight for the delivery of quality project management services, within time and budget
- Oversight for seven (7) projects in oncology, respiratory, nephrology and rare disease indications
- Line management tasks: training, mentoring, performance reviews, hiring, onboarding training, and resourcing of ongoing projects
- Works cross-functionally with other departments (medical, data management, biostatistics, regulatory, medical writing) to ensure seamless operational delivery
- Departmental and study finance management
- Supports with audits and inspections
- Contributes to business development activities with new opportunities.
Director, Project Management
Chiltern International
Madrid
08.2017 - 09.2018
- Responsible for the development and management of projects within the Early Phase Oncology Project Management Division
- Early clinical development of several innovative biological agents (immunotherapy, stem cell, CART, radiotherapy, cancer vaccine)
- Supports with the revision of protocols
- Develops study plans, risk management, oversight and management of project conduct and deliverables
- Departmental and study finance management
- Line management: training, mentoring, performance reviews, hiring, onboarding training, and resourcing of ongoing projects
- Supports with audits and inspections
- Contributes to business development activities with new opportunities.
Associate Director, Project Management
PPD
Madrid
11.2015 - 08.2017
- Responsible for the oversight of projects within the Hematology-Oncology Department
- Team performance oversight to achieve project goals within time and quality standards, providing training to the study teams, ensuring compliance with SOPs, regulations and other guidelines
- Supports with audits and inspections
- Budget management at project and departmental level
- Line management responsibilities.
Vice President, Clinical Operations
Accelsiors CRO
Budapest
03.2014 - 11.2015
- Responsible for leading and coordinating the Clinical Operations Department, which included: Project Management Unit (9 Project Managers), Clinical Operations Unit (5 Clinical Operations Managers, 10 Clinical Team Leads, 50 CRAs and 4 CTAs) and Logistics Unit (2 Project Managers, 3 Associates and 1 Assistant)
- Accountable for the oversight of the company’s portfolio of projects
- Development of company’s’ SOPs and processes, project management dashboards and tools
- Actively supports the QA department with audits and inspections.
Associate Director, Clinical Team Management
PRA International
Madrid
09.2011 - 12.2013
- Ensures Clinical Team Managers´ functional goals are achieved, in accordance with the company mission and objectives
- Hires, resources, mentors, trains, supervises, and evaluates Clinical Team Managers to achieve project goals and fully develop their technical competences
- Provides service delivery consultancy at portfolio level for key sponsors
- Actively involved in initiatives to create and implement SOPs and specific clinical procedures.
Project Director
PRA International
Madrid
07.2010 - 08.2011
- Responsible for conducting a full services phase II/III clinical program in haematology-oncology
- Manages a cross-functional team of Project Managers, Clinical Team Managers, Start Up and Regulatory, Medical, Safety, Data Management, Biostatistics and Medical Writing
- Accountable for achieving milestones and deliverables within time, quality, and budget, as well as for the finance and resource management at program level.
Project Manager/ Senior Project Manager
PRA International
Madrid
02.2006 - 07.2010
- Global Project Manager for two (2) projects, full services, phase III, one in hematology-oncology and other in respiratory
- Regional Project Manager for three (3) projects in hematology-oncology in phases II and III
- These projects vary in size; the largest one had more than ninety (90+) participating sites out of twelve (12) countries across all continents
- Accountable for globally achieving studies deliverables and milestones in time, within quality standards in adherence to ICH-GCP, and within the agreed budget.
Clinical Team Manager
PRA International
Madrid
12.2004 - 01.2006
- Responsible for leading clinical teams of CRAs and in-house CRAs to successfully complete start-up and conduct clinical trials until study closure
- Accountable for all start-up and clinical deliverables, monitoring plan, study templates and study trainings
- Performs trip reports review
- Creates, implements and maintains monitoring visits plan.
Clinical Research Associate (CRA)/ Senior Clinical Research Associate
PRA International
Madrid
12.1999 - 08.2003
- Responsible for conducting clinical trials at site level, from feasibility, site selection and start up, through subject enrollment, treatment and follow up, to site close out, in compliance with all study protocol procedures, ICH-GCP, local regulations and CRO/sponsor´s SOPs
- Conducts clinical trials, mainly phase II and phase III, in hematology and oncology indications.
Project Manager
Tedec-Meiji Pharma
Madrid
04.1996 - 05.1998
- Responsible for managing several phase IV clinical trials in traumatology, rheumatology, and oncology
- Supports investigators with protocol design and implementation of post-marketing trials
- Works closely with the sales network and the marketing department
- Organizes congresses and symposia.
Clinical Research Associate
Tedec-Meiji Pharma
Madrid
09.1994 - 11.1996
- Conducts clinical trials, phases II and III, in infectious diseases and respiratory indications
- Manages sites from site selection, Ethics Committees and regulatory submission, contract execution until activation
- Performs all types of sites visits (pre-study, initiation, monitoring and close out).
Education
Degree in Pharmacy- Biochemistry -
Universidad Complutense de Madrid
01.1994
Skills
- Portfolio Oversight
- Global Team Management
- Clinical Development
- Project Management and Clinical Operations Knowledge
- Financial Acumen
- Critical Thinking
- Risk Management
- Results oriented
- Early Phase clinical trials
Oncologyexperience
- Solid Tumors – Breast (HER2+, Triple negative), Gastro-Intestinal tumors (Pancreatic, Rectal)
- Genito-Urinary Tumors (Renal Cell Carcinoma)
- Gynecological Tumors (Epithelial Ovarian Cancer)
- Head and Neck (Squamous Cell Cancer)
- Thoracic Tumors (Non-Small Cell Lung Cancer Squamous/Non-Squamous, EGFR+, PD-L1 expression)
- Hematologic Malignancies – Leukemia (AML, CLL, CML), Non-Hodgkin’s Lymphoma (Follicular, Mantle Cell Lymphoma), Myelodysplasia, Multiple Myeloma
- Type of Treatment – Chemotherapy, Stem Cell Transplant, Immunotherapy, CAR-T, Radiotherapy, Vaccine
- Phases: I, II, III and IV
Imidexperience
- Systemic – Rheumatoid Arthritis, Osteoarthritis
- Inflammatory Bowel – Ulcerative Colitis, Irritable Bowel
- Inflammatory Respiratory – Asthma, COPD
- Allergy – Allergic Rhinitis
- Phases: All phases
Neuroscienceexperience
- Neurology – Parkinson’s
- Rare Disorders - Amyotrophic Lateral Sclerosis
Infectiousdiseaseexperience
- Bacterial Disease Therapy – Community Acquired Pneumonia, UTI
- Anti-Viral Therapy – Herpes Simplex Virus (HSV), SARS-CoV-2
- Phases: All phases
Otherexperience
- Paroxysmal Nocturnal Hemoglobinuria. Phases II and III
- Anemia secondary to renal disease
- Non-Inflammatory Immunology – Graft vs. Host Disease
- General Hormonal – Growth Hormone Deficiency
- Nephrology – C3 Glomerulonephritis
- Ophthalmology – Achromatopsia, Retinitis Pigmentosa
- Phases: All phases
- Special Patient Population: Pediatric, Elderly
Therapeuticexperience
- Oncology and Hematology
- Rare Diseases
- Nephrology
- Infectious Diseases
- Respiratory
- Traumatology
- Rheumatology
Other
Oracle RDC, Medidata Rave, Medrio, Medidata, Siebel, Bioclinica, Medidata, ClinPhone, Trial Interactive, Veeva, Strong knowledge of Microsoft Office tools and general computer literacy.
Languages
- Spanish, 5
- English, 4
- Italian, 1
- French, 1
- Portuguese, 1
Timeline
Senior Director of Portfolio Management
Bionical Emas
02.2024 - Current
Head of Clinical Operations
Bionical Emas
04.2023 - 02.2024
Head of Compliance and Clinical Monitoring
Bionical Emas
09.2022 - 04.2023
Senior Director, Oncology, Global Project Delivery
LabCorp (previously Covance Inc.)
03.2021 - 05.2022
Vice President, Project Management EU
Clinipace Clinical Research
01.2020 - 01.2021
Director, Project Management
Clinipace Clinical Research
09.2018 - 01.2020
Director, Project Management
Chiltern International
08.2017 - 09.2018
Associate Director, Project Management
PPD
11.2015 - 08.2017
Vice President, Clinical Operations
Accelsiors CRO
03.2014 - 11.2015
Associate Director, Clinical Team Management
PRA International
09.2011 - 12.2013
Project Director
PRA International
07.2010 - 08.2011
Project Manager/ Senior Project Manager
PRA International
02.2006 - 07.2010
Clinical Team Manager
PRA International
12.2004 - 01.2006
Clinical Research Associate (CRA)/ Senior Clinical Research Associate
PRA International
12.1999 - 08.2003
Project Manager
Tedec-Meiji Pharma
04.1996 - 05.1998
Clinical Research Associate
Tedec-Meiji Pharma
09.1994 - 11.1996
Degree in Pharmacy- Biochemistry -
Universidad Complutense de Madrid
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