Clinical Data Management Unit Manager

4 settimane fa

Parma, Italia Chiesi Farmaceutici S.p.A. A tempo pieno

Team: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: 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
  1. To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutions.
  2. To guide the preparation of data package for regulatory submission, contributing to the strategy, briefing book preparation, regulatory interaction and overseeing the activities.
  3. 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.
  4. To ensure consistent approach in CROs management guiding the internal team and interacting with other internal roles.
  5. To develop and maintain internal standards and Standard Operating Procedures.
  6. To support programmers in the review of documents (e.g., Statistical Analysis Plan, Data Review Plan) to ensure clarity and completeness of assumptions and assess impact on programming activity.
  7. To develop innovative statistical programming approaches and technologies in clinical trials.
  8. In collaboration with statistical team, to promote data mining to maximize value of clinical trial data and support hypothesis generation.
  9. To build and maintain network with external statistical and programming teams.
Experience RequiredEducationLanguagesTechnical SkillsSoft Skills#J-18808-Ljbffr

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