Clinical Data Management Unit Manager

1 mese 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
To train all statistical computing users, in collaboration with GICT to maintain the platform and evaluate possible innovative solutions. To guide the preparation of data package for regulatory submission, contributing to the strategy, briefing book preparation, regulatory interaction and overseeing the activities. 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. To ensure consistent approach in CROs management guiding the internal team and interacting with other internal roles. To develop and maintain internal standards and Standard Operating Procedures. 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. To develop innovative statistical programming approaches and technologies in clinical trials. In collaboration with statistical team, to promote data mining to maximize value of clinical trial data and support hypothesis generation. To build and maintain network with external statistical and programming teams. Experience Required
Education
Languages
Technical Skills
Soft Skills
#J-18808-Ljbffr



  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **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...


  • Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITPurposeTo 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...


  • Parma, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    Team: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITPurposeTo 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...

  • Data Management Leader

    4 settimane fa


    Parma, Emilia-Romagna, Italia Chiesi Farmaceutici S.P.A. A tempo pieno

    About the RoleWe are seeking a Data Management Leader to provide technical leadership and ensure high-quality statistical programming in supporting different phases of clinical development. As part of our R&D, Pharmacovigilance & Regulatory Affairs team, you will be responsible for leading a team, providing senior expertise and guidance, planning resources,...


  • Parma, Italia ClinChoice A tempo pieno

    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 an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners, to oversee Clinical Project...

  • Clinical Project Director

    1 settimana fa


    Parma, Italia Clinchoice A tempo pieno

    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 an experienced Senior Project Manager/Director to work with one of our pharmaceutical partners, to oversee Clinical Project...


  • Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno

    About the RoleWe are seeking a highly skilled Clinical Risk Operations Specialist to join our Global Clinical Development team. As a key member of our team, you will play a critical role in supporting and facilitating clinical risk assessment and management activities across our global clinical studies.

  • Unit People

    5 giorni fa


    Parma, Italia IKEA A tempo pieno

    What you'll be doing day to day PURPOSE OF THE JOB Purpose of the job is to be a business partner for Managers and Leaders of the unit to contribute to the unit management team to secure People strategies are locally implemented into action in the most effective and efficient way. Facilitate a working environment where the IKEA values and culture are a...

  • Unit People

    2 giorni fa


    Parma, Italia Ikea A tempo pieno

    What you'll be doing day to dayPURPOSE OF THE JOBPurpose of the job is to be a business partner for Managers and Leaders of the unit to contribute to the unit management team to secure People strategies are locally implemented into action in the most effective and efficient way.Facilitate a working environment where the IKEA values and culture are a living...


  • Parma, Italia IKEA A tempo pieno

    **Job ID**: 256102 **Date posted**: 02/09/2024 PURPOSE OF JOB We take the lead in delivering safe, compliant, sustainable and innovative property solutions - with Democratic design and life cycle cost on top of our mind. We actively maintain and secure that our properties are kept in relevant shape for the business. WHAT YOU'LL NEED TO HAVE - Preferred...


  • Parma, Italia Ikea A tempo pieno

    **Job ID**: 256102**Date posted**: 02/09/2024PURPOSE OF JOBWe take the lead in delivering safe, compliant, sustainable and innovative property solutions - with Democratic design and life cycle cost on top of our mind. We actively maintain and secure that our properties are kept in relevant shape for the business.WHAT YOU'LL NEED TO HAVE- Preferred experience...


  • Parma, Italia IQVIA A tempo pieno

    On behalf of our Client a global pharmaceutical company, IQVIA is looking for **a e-TMF Specialist - Supply section** who can join an exciting working environment in a dynamic atmosphere. **RESPONSIBILITIES**: - To review eTMF plans - To upload documents in the eTMF and perform ongoing quality control of the eTMF (Investigational products and Clinical...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:4 Nov 2024**Department**:Global Pharmacovigilance**Team**:R&D, Pharmacovigilance & Regulatory Affairs**Job Type**:Direct Employee**Contract Type**:Permanent**Location**:Parma, IT**_About us_** - Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:Dec 21, 2024 **Department**:AIR Franchise **Job Type**:Intern **Team**:Mktg, Market Access, Bus. Excellence & Med. Affair **Contract Type**:Temporary **Location**:Parma, IT **_About us_** - Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31...


  • Parma, Italia Iqvia A tempo pieno

    On behalf of our Client a global pharmaceutical company, IQVIA is looking for **a e-TMF Specialist - Supply section** who can join an exciting working environment in a dynamic atmosphere.**RESPONSIBILITIES**:- To review eTMF plans- To upload documents in the eTMF and perform ongoing quality control of the eTMF (Investigational products and Clinical Trial...


  • Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:4 Nov 2024**Department**:Global Pharmacovigilance**Team**:R&D, Pharmacovigilance & Regulatory Affairs**Job Type**:Direct Employee**Contract Type**:Permanent**Location**:Parma, IT**_About us_**- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31...


  • Parma, Italia Chiesi Group A tempo pieno

    Who we are looking forPurposeTo support and facilitate the clinical risk assessment and management activities in GCD clinical studies in compliance with regulations and guidelines (including escalation and specific reporting).Main ResponsibilitiesCollaborates with GCD (Global Clinical Development Dept) clinical study teams for:•    Quality-by-design...


  • Parma, Emilia-Romagna, Italia Chiesi A tempo pieno

    About UsChiesi, a leading pharmaceutical and healthcare company, is based in Parma, Italy. With over 85 years of experience and operations in 31 countries, the company has a strong presence globally.We are committed to improving people's quality of life by acting responsibly towards society and the environment. Our mission drives us to research, develop, and...


  • Parma, Italia ClinChoice A tempo pieno

    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 Clinical Trial Assistant (CTA) to join an international pharmaceutical company, with a focus on Respiratory, Paediatrics,...


  • Parma, Italia ClinChoice A tempo pieno

    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 Clinical Trial Assistant (CTA) to join an international pharmaceutical company, with a focus on Respiratory, Paediatrics,...