Offers “Sanofi”

Expires soon Sanofi

Clinical Supply Study Manager

  • Bridgewater (Somerset)

Job description

Sanofi Recherche et Développement look for:

CLINICAL SUPPLY – STUDY MANAGER (M/F)

Job Description:

In C2SPM (Clinical Supply Study & Management) department of Sanofi Recherche et Développement, the Clinical Supply Study Manager (CS-SM) is accountable for the clinical supply operational management in a clinical trial. The CS-SM is responsible to ensure for each study he/she has under supervision that supplies are delivered on time, within budget and in compliance with GXP’s, SOPs, and standards. 

The CS-SM is responsible of the coordination of CS-CO team in order to ensure the execution of the clinical supply study activities. 

The CS-SM collaborate with different stakeholders to define the most optimized settings. The CS-SM is responsible to set-up the best strategy for the study setting and communicate to the study team. 

He/she oversees a Clinical Supply Production Plan for a study and ensure progress according to study timelines. He/she leads the Operational Supply Meetings. He/she should ensure study activities are aligned with the projections. If not, he/she has to revise the strategy to optimize the clinical supply chain and mitigate any risks.

He /she is the key contact to the Global Study Manager in charge of the study and she/he is part of the Core Study team, as the leader and expert for clinical supply activities. 

He/she contributes to the review of the study documentation (Protocol, Monitoring Plan, Pharmacy manual/Instructions for Use, and CRA presentations) especially for the IMP/NIMP impacts and discusses the design of the study for streamlining the use of supply in the study. He/she is also responsible for the preparation of study related materials, documents in order to support the local team for the site initiation.

He/she is also responsible to coordinate the discussion for the devices sourcing strategy.

He/she reports to the Therapeutic Area Group Head. 

Responsibilities:

· 
Coordinates overall CSCO operations of the entire clinical study including study planning, budget, resource management, regulatory practices, policy adherence and contract research organization management (when applicable)

· 
Develop study related documents and IMP preparation directions for the clinical sites

· 
IRT set-up and follow-up  

· 
Organize CSCO study meetings

· 
Problem solving: Propose actions and mitigations plans for decision making

· 
Collect, synthesize and report study information

Required Education/Experience

· 
Bachelor of Science degree (BS) in Health Science or related discipline

· 
2+ years’ experience in pharmaceutical business required.

· 
Previous experience in clinical development.

Additional Experience:

The individual must be well versed in all aspects of the clinical supply chain process, GMP, GDP, and other regulatory requirements as they pertain to investigational products.

Leadership

· 
Able to lead the WW supply team (into CSCO)

· 
Able to lead transversal activities

· 
Able to challenge / decisions/ status-quo with teams including study team

· 
Able to promote the team spirit and the Collaborative mindset

Oversight and coordination

· 
Good Project Management skills

· 
Good organizational skills and multi-tasking skills (Effective time management skills)

· 
Sense of urgency, prioritize workload with dynamic, culturally diverse organization

· 
Able to work autonomous and providing appropriate reporting to study team and CS Study Leader or CS POL

· 
Able to oversee all other supply activities (CSPM, external vendor etc…)

Communication

· 
Good communication skills (written and oral),

· 
Good negotiation skills, strong problem-solving skills.

Decision Making & problem solving

· 
Able to identify and anticipate risk

· 
Able to provide mitigation plan, actions plan for decision making

· 
Able to solve problem and make decisions when needed

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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