Clinical Data Management Unit Manager Parma

Clinical Data Management Unit Manager
Parma
Emilia Romagna, Parma

PurposeTo provide technical leadership and ensure high quality statistical programming in supporting different phases of clinical development in compliance with standards and regulatory requirementsTo 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 strategyProcess owner of the Statistical Computing environment, to ensure compliance with Computer System ValidationMain ResponsibilitiesRES: To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutionsRES: To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutionsRES: 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/requirementsRES: To ensure consistent approach in CROs management guiding the internal team and interacting with other internal rolesRES: To develop and maintain internal standards and Standard Operating ProceduresRES: 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 activityRES: 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 generationRES: To build and maintain network with external statistical and programming teamsExperience RequiredEducationLanguagesTechnical SkillsSoft Skills