Clinical Data Management Unit Manager
Parma, IT
Purpose
To provide technical leadership and ensure high quality statistical programming in supporting different phases of clinical development in compliance with standards and regulatory requirements
To lead the team providing senior expertise and guidance, planning resources, recruiting, mentoring and developing the team
To foster the power of data collaborating with statisticians in data-mining and exploratory analysis and promoting innovative approaches / innovative tools in line with the overall GCD strategy
Process owner of the Statistical Computing environment, to ensure compliance with Computer System Validation
Main Responsibilities
RES: To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutions
RES: To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutions
RES: To guide the preparation of data package for regulatory submission, contributing to the strategy, briefing book preparation, regulatory interaction and overseeing the activities
RES: To oversee the execution of all programming activities reviewing key documents to ensure high quality reporting is in line with study documents, internal standards, regulatory guidelines/requirements
RES: To ensure consistent approach in CROs management guiding the internal team and interacting with other internal roles
RES: To develop and maintain internal standards and Standard Operating Procedures
RES: To support programmers in the review of documents (eg. Statistical Analysis Plan, Data Review Plan) to ensure clarity and completeness of assumptions and assess impact on programming activity
RES: To develop innovative statistical programming approaches and technologies in clinical trials
RES: In collaboration with statistical team, to promote data mining to maximize value of clinical trial data and support hypothesis generation
RES: To build and maintain network with external statistical and programming teams
Experience Required
Education
Languages
Technical Skills
Soft Skills
Screen readers cannot read the following searchable map.
Follow this link to reach our Job Search page to search for available jobs in a more accessible format.