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 Leaders who are in charge of clinical studies. This can be a home based position, with occasional visits to the office. It will initially be a Fixed Term Contract for 18 months to cover maternity leave.
**Main Job Tasks and Responsibilities**:
- Oversight and operational management of clinical Trials from study design until study close-out, ensuring on time and on budget completion, with adherence to the required quality standards and compliance with ICH, GCP and Company's Standard Operating Procedures (SOPs).
- Design and development of full synopsis and protocol by leading cross-functional team members.
- Management of the CRO by acting as primary contact, managing day-to-day relationships, raising issues as soon as they are identified.
- Management of study budget, scope changes and financial reconciliation.
- Preparation and coordination of scientific meetings incl. KOLs meeting, Investigators' meeting, blinded review meeting.
- Preparation, review and approval of Clinical Study Report (CSR) in cooperation with the Medical Writer and other required key team stakeholders.
- Reporting to Company's senior management.
- Operational management coordination of assigned projects.
- Clinical Development Plan (CDP) definition in relation to studies' operational aspects.
- Interactions with all functions supporting the Clinical Development Plan.
- Line Management of Clinical Project Managers (CPMs).
- Oversight of CPMs involved in different trials of assigned programs.
**Education, Experience and Skills**:
- University Degree in scientific, pharmacy or other health related discipline, or equivalent.
- Proven experience as Clinical Project Manager.
- Strong knowledge of clinical study design, clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
- Knowledge of planning tools and planning principles.
- Knowledge of GLP for bio analytical assays.
- Knowledge of Trial Master File.
- Fluent in English and local language(s).
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).
- Willingness to travel.
**The Application Process**:
**Who will you be working for?**
**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
**Key words**: Clinical Project Manager, Clinical Project Director, CPM, CPD, Respiratory, Freelance, Permanent, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated
LI-CM1 #LI-FULLTIME

  • Clinical Project Director

    3 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...

  • Junior Clinical Project Manager

    6 giorni fa

    Parma, Italia JSB SOLUTIONS S.R.L A tempo pieno

    JSB Solutions, azienda di consulenza nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Junior Clinical Project Manager**: - (JSB.FRK.22.007)_ che abbia maturato **almeno 6 mesi **di esperienza in ruoli simili. **team della nostra CRO **e si occuperà di collaborare operativamente agli studi ad essa assegnati. -...

  • Junior Clinical Project Manager

    4 giorni fa

    Parma, Italia Jsb Solutions S.R.L A tempo pieno

    JSB Solutions, azienda di consulenza nata nel 2009 con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un**Junior Clinical Project Manager**:- (JSB.FRK.22.007)_ che abbia maturato**almeno 6 mesi **di esperienza in ruoli simili.**team della nostra CRO **e si occuperà di collaborare operativamente agli studi ad essa assegnati.- assicurarsi che...

  • Clinical Trial Assistant

    7 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,...

  • Clinical Trial Assistant

    7 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,...

  • Clinical Risk Operation Specialist

    3 settimane fa

    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...

  • Clinical Trial Assistant

    2 settimane 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,...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:13 Dec 2024 **Department**:Global Clinical Development **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,...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**:13 Dec 2024**Department**:Global Clinical Development**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 Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi A tempo pieno

    About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 13 Dec 2024 Department: Global Clinical Development 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 countries with more...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 13 Dec 2024 Department: Global Clinical Development 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 countries with more...

  • Clinical Risk Operation Specialist

    2 settimane fa

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

    Select how often (in days) to receive an alert: 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 countries with more than 7,000...

  • Clinical Risk Operation Specialist

    2 settimane fa

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

    Select how often (in days) to receive an alert: 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 countries with more than 7,000...

  • Clinical Risk Operation Specialist

    2 settimane fa

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

    Select how often (in days) to receive an alert:Team: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation:Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 13 Dec 2024Department: Global Clinical DevelopmentTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...

  • Clinical Risk Operation Specialist

    3 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    Date: 13 Dec 2024Department: Global Clinical DevelopmentTeam: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITAbout us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than...

  • 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,...

  • Global Medical Affairs Clinical Operations Intern

    2 settimane fa

    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...

  • Global Medical Affairs Clinical Operations Intern

    2 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7,000 employees (Chiesi Group).To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches,...