CROS NT’s clinical data management team have extensive knowledge in the management of data generated in Phases I-IV trials.
In this blog we talk to Monica Pimazzoni, Director of Clinical Data Management, who is based in Verona, to find out more about her career path, current role at CROS NT and her interests outside of work.
When did you identify data management as the right career for you?
It was just destiny. When I completed my studies in late 80’s I decided to spend some months in UK to improve my English. Whilst making the arrangements I sent my CV speculatively to a local big pharma company and just before I headed off to the UK I got a call for an interview and one month later I started in Glaxo as Clinical Data Monitor. I did not know anything about clinical research and the clinical data manager role was still at its early days without a definite and detailed job description. When I started, Glaxo Italy was in the middle of Lacidipine registration (a drug for hypertension), I was taken in a brand new world made of investigational sites, investigators, CRAs, clinical data, queries, listings and tables, data analysis, and I fell in love with it.
A clinical data manager has a variety of responsibilities, starting from contributing to the development of clinical study protocol, ensuring that it contains all the required details to allow to develop the case report form specifications. The data manager drives all the activities in order to build the clinical database (in majority of the cases the e-CRF), developing documents such the Data Management Plan, Data Validation Plan, User Acceptance Testing Plan, CRF Completion guidelines etc.
What has been your journey to your current role at CROS NT?
I spent most of my career at GSK (passing through different mergers from Glaxo, to GlaxoWellcome to GSK), in 2010 GSK decided to terminate the research in Neurosciences and the GSK R&D in Verona was shut down. Fortunately, Dr Morelli, the owner and CEO of CROS NT contacted me and I was offered the position of Head of Data Management, and here I am 10 years later.
What functions do you collaborate closely with?
I collaborate with many different functions; internally I have day-to-day interactions with project managers, study managers biostatisticians, statistical programmers, Quality Assurance. External relationships are also a key part of my role, working in a CRO I am in regular contact with Sponsors, clinical CROs, third party vendors (e.g. ePRO vendors, software developers etc).
There is never a dull day and I love the fact I am learning something new every day; this ensures I continue to improve my knowledge.
Why are these relationships important?
I think good relationships are paramount to achieving success in what we do, this is important from a personal and business perspective. If you have a strong network of people and you are a trusted person, known for being reliable and honest, you can then build winning, cohesive and supportive teams that help you to achieve company objectives.
What career achievements are you most proud of?
I have achieved a lot in terms of personal and professional development, I had many opportunities to go beyond the ‘normal’ data management services, I recall a business trip to South Africa to perform an on-site audit to a CRO, it was a thrilling experience. I am proud of what I have learnt and achieved in these 30 years, I am proud of the knowledgeable people I had the pleasure to work with, and above all I am proud of my team in CROS NT, I have very committed data managers and database programmers, eager to learn, passionate in what they do, willing to go beyond boundaries and challenge themselves.
What most inspires you about working in this field?
I like the scientific part of my job; I know that a small piece of what I do; is contributing to bringing new drugs onto the market for patients who do not have medicines to treat their conditions or to improve their quality of life. It’s a drop in the ocean, but I know that I am doing something that will help people to feel better and I am proud of it.
What are the top three attributes or technical competencies a data manager must have?
- Organisational and planning skills are paramount.
- Precision is an important attribute that is required in this role.
- Technical skills – knowledge of the CROS NT EDC systems represents added value, experience with coding using MedDRA and Who-Drug, experience in managing third-party vendors and reconciliation of external data, knowledge of CDASH and SDTM.
What are your personal values?
Integrity, passion and commitment. I love my job and I put my heart in what I do, I have never felt it boring, every day there are new challenges and what is important, it is an evolving role.
How do you balance life and work?
As I said I love my job but do have several interests outside of work. I can’t survive without reading a book, my house is disseminated by books. I love animals, especially cats and ‘Pascia’ is my best friend, a wonderful light brown long fur cat, the name itself tells you who rules the house (“Pasha” is the name in English). I like travelling around the world, I am planning a trip to Greece, visiting the Meteora monasteries and their surroundings, I believe visiting other countries and experiencing different cultures helps us to broaden our horizons and gain a real understanding of people.
Would you like to join our talented team? If you think you are the right person for us, please have a look at the job positions currently open.