Maria Dini
Roma
Overview
20
20
years of professional experience
Work History
Associate Director Clinical Operations
MSD, Pharmaceutical Company
- Accountable for the end to end performance and project management for assigned Protocols in the country in compliance with ICH/GCP
- Main point of contact between the Global clinical trial team
- Lead local teams to high performance
- Customer facing role, building Business relationship and represent the company with the customers
- Support local and global Strategy development consistent long term corporate needs.
Clinical Research Associate Manager
Novartis, Pharmaceutical Company
05.2018 - 06.2023
- People and resources management
- Responsible for the hiring, training, coaching, development and retention of a team of CRAs to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials Delivery of quality data and compliance to quality standards
- Accountable for monitoring quality by overseeing CRA performance
- Responsible for internal and external CRAs quality and compliance of clinical monitoring activities related to investigator site qualification, initiation, and trial conduct (recruitment, quality data collection)
- Responsible for CRA performance to KQI’s, ensuring implementation and appropriate application of established Monitoring procedures and tools in accordance with GCP, ICH, SOP’s, and local regulations
- Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues Allocation, initiation and conduct of trials
- Strategically and operationally involved in allocating new trials in collaboration with Country/Cluster/Development Unit Head and local Medical Director teams during trial feasibility phase
- Trial Monitoring strategy
- Collaborate with Trial Monitoring Country Head to implement country innovative practices and patient engagement tactics to advance clinical trial planning, execution and quality
Senior Clinical Study Manager
Novartis, Pharmaceutical Company
05.2013 - 05.2018
- Accountable for planning, executing and reporting, (from site feasibility up to and including study close-out), of assigned Innovative Medicines Phase I-IV Global Drug Development studies in compliance with Novartis processes and regulatory requirements
- Single point of contact and local study team lead, within the Country/Cluster, for the assigned studies
- Accountable to communicate with and support relationships with clinical investigators in collaboration with Country medical/clinical colleagues, global clinical teams and directs activities to execute and deliver their assigned studies
- Lead and chair local study team meetings, attend and participate in global clinical trial team Meetings
- Respect of study commitment and budget supervising
- Documentation management; develop study related documents Therapeutic Areas: Neuroscience and Endocrinology, Ophtalmology, Immnulology and Dermatology
Senior CRA
ICON plc
01.2013 - 05.2013
- Monitoring activities of clinical studies (feasibility, site initiation, monitoring and close out visits)
- Ensuring conduct of Clinical Trial with ethical, scientilic & quality standards, in compliance with ICH-GCP, national & international regulatory Guidelines
- In the following area: Rheumatology studies for Eli Lilly Company
Clinical Study Manager ( Novartis outsourcing)
OPIS srl
05.2012 - 01.2013
- Responsible for planning, executing and reporting of Phase I-IV Global trials From site feasibility through study close-out, in compliance with Novartis processes and regulatory requirements
- Responsible to recognize potential challenge within the protocol and operational aspects of the trial
- Provide training as needed for monitoring and any other activities that support site readiness to recruit
- Drive the conduct of the trial, track and oversee progress and status
- Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues
- Appropriately escalate issues in a timely manner and ensure resolution
- Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
Project Manager
OPIS srl
07.2011 - 05.2012
- Oversee the conduct of a clinical trials to ensure the quality and integrity of data produced at Investigator sites, in accordance with ICH-GCP and Pharma Companies SOPs
- Monitoring activities coordination of CRAs for international clinical studies (phase II-IV) sponsored by Novartis Pharma, in the following areas:, Neurology, Cardiology, Immunology, Rheumatology, Metabolic Diseases and Pneumology
- CRAs training (co-monitoring visits at Sites and mentoring/training at CRO) Sites monitoring as per the Italian Ministerial Decree dated 31 March 2008 Contribute to the preparation of clinical program documents
CRA to monitoring ( Novartis outsourcing)
OPIS srl
10.2007 - 12.2008
- Monitoring activities of clinical studies (feasibility, site initiation, monitoring and close out visits)
- Ensuring conduct of Clinical Trial with ethical, scientific & quality standards, in compliance with ICH-GCP, national & international regulatory Guidelines
- In the following areas: Hematology, Oncology, Neurology, Metabolic Disorders, Cardiology, Immunology, Rheumatology and Pneumology
- Qualified to conduct monitoring activities as per Ministerial Decree dated 31 March 2008
Scientific Information Provider Specialist, Medical Information Sciences
Eli Lilly S.p.A
10.2007 - 12.2008
- Revision of promotional material sent to AIFA, participation in Model Management Product Marketing, preparation of documentation required to handbooks therapeutic hospital and regional hospital (PTO, PTOR), participation in national meeting in order to give support to the medical and scientific public; bibliographic research, database management for the payment of copyright for authors, remote support to patients, physicians and pharmacists about the drugs business.
Pharmacist
Farmacia Della Nave
07.2003 - 09.2007
- Drug retailing and prapration
- Exellent skills in drug manufactoring and long experience in client facing selling.
Education
Master Level II in “Market Access farmaci e dispositivi medici dal laboratorio al paziente” -
Altems, Alta Scuola di Economia e Management dei Sistemi Sanitari, University Cattolica del Sacro Cuore in Rome
Stage -
Pharmades and PEG (Pharma Education Center), via dei Pratoni, 50018 Scandicci (Fi) Pharmaceutical Development and Service srl
Master Level II in "Industrial Pharmaceutical Technologie" -
University of Siena
Authorization to practice the profession of pharmacist. -
University of Firenze
06.2003
Degree in Pharmacy with a An experimental thesis carried out at the laboratory of the Department of Physiology University of Florence, "The effects of Sphingosine-1-phosphate, (S1P), on the movement of charge of Calcium channels of the L-type, in mammalian skeletal muscle -
University of Firenze
04.2003
Skills
- Crisis Management
- Strategic Leadership
- Resources Allocation
- Expense Control
Consent
In compliance with the Italian legislative Decree no. 196 dated 30/06/2003 and with the article n.13 of the European General Data Protection Regulation 2016/679, I hereby authorize you to use and process my personal details contained in this document
Skills And Competences
Mother tongue, Good, Good, Good, Excellent Communication and Interpersonal skills, Customer Insight, Negotiation, Coaching, Ability to work under stress, Positive Attitudes towards novelty, change and innovation.. Responsible for the management and coaching of an assigned team. Develop deep understanding of individual stakeholder needs and identify mutually beneficial solutions for both Company and customers through creation of relationships within targeted accounts Manage day to day operational aspects of function, Licence B
Personal Information
- Date of Birth: 01/13/76
- Nationality: Italian
Timeline
Clinical Research Associate Manager
Novartis, Pharmaceutical Company
05.2018 - 06.2023
Senior Clinical Study Manager
Novartis, Pharmaceutical Company
05.2013 - 05.2018
Senior CRA
ICON plc
01.2013 - 05.2013
Clinical Study Manager ( Novartis outsourcing)
OPIS srl
05.2012 - 01.2013
Project Manager
OPIS srl
07.2011 - 05.2012
CRA to monitoring ( Novartis outsourcing)
OPIS srl
10.2007 - 12.2008
Scientific Information Provider Specialist, Medical Information Sciences
Eli Lilly S.p.A
10.2007 - 12.2008
Pharmacist
Farmacia Della Nave
07.2003 - 09.2007
Associate Director Clinical Operations
MSD, Pharmaceutical Company
Master Level II in “Market Access farmaci e dispositivi medici dal laboratorio al paziente” -
Altems, Alta Scuola di Economia e Management dei Sistemi Sanitari, University Cattolica del Sacro Cuore in Rome
Stage -
Pharmades and PEG (Pharma Education Center), via dei Pratoni, 50018 Scandicci (Fi) Pharmaceutical Development and Service srl
Master Level II in "Industrial Pharmaceutical Technologie" -
University of Siena
Authorization to practice the profession of pharmacist. -
University of Firenze
Degree in Pharmacy with a An experimental thesis carried out at the laboratory of the Department of Physiology University of Florence, "The effects of Sphingosine-1-phosphate, (S1P), on the movement of charge of Calcium channels of the L-type, in mammalian skeletal muscle -
University of Firenze
Similar Profiles
Dominic GriffithDominic Griffith
Project Manager at MSD Biotech PharmaceuticalProject Manager at MSD Biotech Pharmaceutical
Manish KumarManish Kumar
Field Manager at MSD Pharmaceutical LtdField Manager at MSD Pharmaceutical Ltd
Matthew DuffyMatthew Duffy
Electrician at MSD Pharmaceutical PlantElectrician at MSD Pharmaceutical Plant
Glenn AndersonGlenn Anderson
Managing Director at GPA Electrics Pty Ltd T/as Roma Electrical & AirManaging Director at GPA Electrics Pty Ltd T/as Roma Electrical & Air
Elisa SinghElisa Singh
Child Safety Officer at Queensland Government - Department of Child Safety, Youth and WomenChild Safety Officer at Queensland Government - Department of Child Safety, Youth and Women