Clinical Data Management Unit Manager Parma

Clinical Data Management Unit Manager
Parma
Emilia Romagna, Parma

Date**:12 Nov 2024**Department**:Global Clinical Development**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

- 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