Clinical Data Management Unit Manager

2 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
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

  • Clinical Data Management Unit Manager

    3 settimane fa

    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...

  • Clinical Data Management Unit Manager

    2 settimane fa

    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...

  • Clinical Data Management Unit Manager

    2 settimane fa

    Parma, Italia Chiesi A tempo pieno

    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 providingsenior expertise and guidance, planning resources, recruiting, mentoring and developing the team To foster the power of data...

  • Clinical Data Management Unit Manager

    3 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    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...

  • Clinical Data Management Unit Manager

    2 settimane fa

    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...

  • Clinical Data Management Unit Manager

    2 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...

  • Clinical Data Management Unit Manager

    3 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    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...

  • Clinical Data Management Unit Manager

    2 settimane fa

    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 Team Lead

    2 settimane fa

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

    Job OverviewWe are seeking an experienced Data Management Team Lead to join our Clinical Trials team at Chiesi Group.Key ResponsibilitiesTo 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...

  • Unit Facility Management Director

    4 settimane fa

    Parma, Emilia-Romagna, Italia Ikea Gruppe A tempo pieno

    Job SummaryWe are seeking a highly skilled Unit Facility Management Manager to lead the execution of Ingka Facility Management within the unit(s) through the unit FM team.Main ResponsibilitiesLead and manage the execution of Ingka Facility Management (FM) within the unit(s) through the unit FM teamResponsible for ensuring each property is managed throughout...

  • Unit Facility Management Manager

    5 mesi fa

    Parma, Italia Ikea Gruppe A tempo pieno

    What you'll be doing day to day • Lead and manage the execution of Ingka Facility Management (FM) within the unit(s) through the unit FM team • Responsible to make sure that each property is managed throughout its lifetime including safety, compliance, maintenance and improvement to ensure a safe and operational environment for the business, colleagues,...

  • Unit Facility Management Manager

    5 mesi fa

    Parma, Italia Ikea Gruppe A tempo pieno

    What you'll be doing day to day • Lead and manage the execution of Ingka Facility Management (FM) within the unit(s) through the unit FM team• Responsible to make sure that each property is managed throughout its lifetime including safety, compliance, maintenance and improvement to ensure a safe and operational environment for the business, colleagues,...

  • Clinical Project Director

    2 mesi 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...

  • Statistical Programming Leadership and Innovation Manager

    3 settimane fa

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

    Job DescriptionWe are seeking an experienced Statistical Programming Leadership and Innovation Manager to join our Clinical Data Management Unit at Chiesi Group.The successful candidate will provide technical leadership and ensure high-quality statistical programming in supporting different phases of clinical development, in compliance with standards and...

  • Global Pharmacovigilance Operations Manager

    4 settimane fa

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

    About the RoleWe are seeking a skilled Global Pharmacovigilance Operations Manager to support the Global Pharmacovigilance Team in executing and overseeing pharmacovigilance operations activities within the Air Business Unit.Main ResponsibilitiesKey Functions:Collaborate with the Global PV Operations Unit Head, Air in planning GPV Ops activities on specific...

  • Unit Facility Management Specialist

    3 mesi fa

    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...

  • Gpv Operations Unit Head, Care

    2 settimane fa

    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...

  • Clinical Trial Administrator

    4 settimane fa

    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...

  • GPV Operations Unit Head, Care

    2 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose The “Global Pharmacovigilance Operations Unit Head, Care” supports the Global Pharmacovigilance Team (within R&D) in the execution and oversight of premarket and postmarket pharmacovigilance operations activities within the “Care” Business Unit. Main Responsibilities •    Collaborate...

  • Clinical Trial Assistant

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