Sanofi
Clinical Operations Leader - VIE Contract
Sanofi, Marcy, New York, United States,
Clinical Operations Leader - VIE Contract
Location:
USA, SwiftwaterTarget start date:
01/11/2024iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.About the jobLooking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Clinical Operations Leader in our Team, you’ll be working in close collaboration with the extended Clinical team and under the responsibility of experienced Clinical Operation Leaders (COL) for the respective assigned project(s). You will provide support to the COL platform and/or Global Clinical Development department via non-project activities such as working groups or initiatives as applicable.We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Main responsibilities:Coordinate extended Clinical team member identification.Attend/contribute to project team meetings/activities & extended Clinical team meetings/activities. Lead & follow-up extended Clinical team meetings. Coordinate Clinical CTD (Common Technical Document) task force & participate in PAI (pre-approval inspection) preparation/conduct/closure.Routinely meet with GCDSE (Global Clinical Development Strategy Expert) to collaborate on the project & team management.Ensure proper team management & leadership with regard to creating/maintaining good team spirit & collaboration, respect franchise/project strategy & timelines, efficient issue/risk/escalation management, challenge the team to implement innovative solutions and bold ideas.Review and contribute to Clinical operational strategy documents (Target Product Profile - TPP, Clinical Development Plan - CDP, etc.).Use clinical project analytics to communicate on issues/risks/alerts.Timely & accurate set-up/maintenance of the project plans within planning tool (RDPM) on monthly basis and according to T1/strat plan/T2 requirements. Set up simulations upon request.Timely & accurate update (eCote specifications, RDPM) & review/comment (CASA report) of the budget on monthly basis and according to T1/strat plan/T2 requirements.Timely & accurate information provided for: 1) Investigational product (IP) planning, 2) Timecard and 3) Routine meetings with Sanofi supervisor to provide updates on project & non-project activities.Attend & participate in process/tools oriented & COL requested meetings (COL forum). Contribute to COL process improvements or Sanofi working groups. Act as subject matter expert. Perform training related to job certification.About youExperience:At least 1 year of professional experience in clinical studies and project management.Soft and Technical skills:Knowledge of Clinical trial operations and experience leading or working within a multi-functional team (e.g. Clinical project or study team).Strong organizational skills, interpersonal and communication skills.Customer and quality focused.Self-directed, motivated and results driven with ability to manage multiple priorities and projects.Proactive with ability to drive decision making process.Conflict management and problem solving skills.Influencing and negotiating skills.Culturally savvy and high emotional intelligence.Familiarity with project management software & Office 365.Experience with Agile or Scrum methodology & tools is a plus.Education:Master’s degree in relevant scientific and/or medical field.Languages:Fluent English communication skills, written and verbal.Why choose us?iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.#LI-EUR
#J-18808-Ljbffr
Location:
USA, SwiftwaterTarget start date:
01/11/2024iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.About the jobLooking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Clinical Operations Leader in our Team, you’ll be working in close collaboration with the extended Clinical team and under the responsibility of experienced Clinical Operation Leaders (COL) for the respective assigned project(s). You will provide support to the COL platform and/or Global Clinical Development department via non-project activities such as working groups or initiatives as applicable.We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.Main responsibilities:Coordinate extended Clinical team member identification.Attend/contribute to project team meetings/activities & extended Clinical team meetings/activities. Lead & follow-up extended Clinical team meetings. Coordinate Clinical CTD (Common Technical Document) task force & participate in PAI (pre-approval inspection) preparation/conduct/closure.Routinely meet with GCDSE (Global Clinical Development Strategy Expert) to collaborate on the project & team management.Ensure proper team management & leadership with regard to creating/maintaining good team spirit & collaboration, respect franchise/project strategy & timelines, efficient issue/risk/escalation management, challenge the team to implement innovative solutions and bold ideas.Review and contribute to Clinical operational strategy documents (Target Product Profile - TPP, Clinical Development Plan - CDP, etc.).Use clinical project analytics to communicate on issues/risks/alerts.Timely & accurate set-up/maintenance of the project plans within planning tool (RDPM) on monthly basis and according to T1/strat plan/T2 requirements. Set up simulations upon request.Timely & accurate update (eCote specifications, RDPM) & review/comment (CASA report) of the budget on monthly basis and according to T1/strat plan/T2 requirements.Timely & accurate information provided for: 1) Investigational product (IP) planning, 2) Timecard and 3) Routine meetings with Sanofi supervisor to provide updates on project & non-project activities.Attend & participate in process/tools oriented & COL requested meetings (COL forum). Contribute to COL process improvements or Sanofi working groups. Act as subject matter expert. Perform training related to job certification.About youExperience:At least 1 year of professional experience in clinical studies and project management.Soft and Technical skills:Knowledge of Clinical trial operations and experience leading or working within a multi-functional team (e.g. Clinical project or study team).Strong organizational skills, interpersonal and communication skills.Customer and quality focused.Self-directed, motivated and results driven with ability to manage multiple priorities and projects.Proactive with ability to drive decision making process.Conflict management and problem solving skills.Influencing and negotiating skills.Culturally savvy and high emotional intelligence.Familiarity with project management software & Office 365.Experience with Agile or Scrum methodology & tools is a plus.Education:Master’s degree in relevant scientific and/or medical field.Languages:Fluent English communication skills, written and verbal.Why choose us?iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.#LI-EUR
#J-18808-Ljbffr