Senior Clinical Data Manager -Remote

Senior Clinical Data Manager -Remote
at ClinChoice (View all jobs)
Siena, Italy
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Senior Clinical Data manager Consultant who is fluent in Italy. The ability to communicate effectively in Italian, both verbally and in writing, is essential for this roleto support one of our biotechnology client. This is a remote opportunity in Sienna, Italy.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Summary
The Senior Clinical Data manager Consultant will have responsibility for the management of Clinical Data of client current clinical trials.
Main Job Tasks and Responsibilities:
The successful candidate will be responsible for supporting the data management group from study start-up through database lock and clinical study reports by:

• Providing expert guidance and support to the Clinical Data Management team and the cross-functional team in the clinical trials development process.
• Providing timely and accurate management of clinical trial data ensuring an end-to-end high-quality process, including analysis of Clinical Data and reports ;Reviewing and contributing to the development of the trial validation plan, including the full protocol package (i.e.: clinical trial, CRF, operations manuals related documents)
• Supporting the centralized monitoring through a smooth peer-to-peer collaboration with the monitoring team.
• Developing plans to help improve standard operating procedures or efficiencies
• Training new employees on how to perform their job duties.

Qualifications and Experience:

• Bachelor’s degree in healthcare or a related field.
• Fluency in Italian is required
• Some experience with clinical trial research and/or data collection.
• Ability to apply statistical knowledge and skills to the analysis of complex data sets.
• Knowledge of clinical research procedures and regulations.
• Meticulous attention to detail.
• Strong organizational.
• Ability to work independently without supervision.
• Ability to prioritize tasks and handle multiple projects at once and stressful situations.
• Knowledge of clinical research procedures and regulations.
• Good knowledge of programming language SAS.
• Good knowledge of MS Excel and Office packages in general.
• Good skills in data analysis.
• Ability to communicate effectively (both verbally and in writing).
• A clear understanding of the benefits of clinical trial research.

Preferred skills

• Knowledge of medical terminology with expertise in oncology preferred.
• Knowledge of coding dictionaries (MedDRA, WHO drug).
• SAS Pheedit experience.

The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
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