Local Study manager

Location: Yakum (Israel)

Job type: Unlimited term, Full time

50% remote working

About The Job

As Local Study Manager (LSM), you will determine technical and financial resources required to implement international protocols in order to conduct clinical studies satisfying the development strategy of sanofi compounds. You will constitute the preferential link between the Corporate Monitoring Teams and the CSU in the framework of the assigned trials.

Main Responsibilities

• Ownership and oversight of all study aspects: financial planning and budget tracking, good site activation, monitor study progress, review monitoring visit reports, ensure recruitment progress according to target, ensure proper safety reporting, etc... In particular ensure that the Investigators are perfectly informed of the specific features of the study and its organization
• Ensure the fulfilment of clinical study objectives defined in the protocol (number of patients and centres, timelines, budget);.
• Collaborate, when applicable, with the Medical Advisors during the feasibility study process
• Prepare Clinical study budget
• Conduct site qualification visits; select potential investigating centres according to their qualifications, clinical experience, research background and areas of expertise, in agreement with the CSU head, Medical Advisor and Team Manager
• Prepare and/or delegate the initial submission of the project to the Ethics Committees and Health Authorities
• Actively ensure the obtaining of any study related documentation required for CTA application according to local regulation and Corporate & local QDs
• Finalize and/or delegate the financial agreements (negotiation with the investigator, hospital, pharmacy, etc.).
• Organize local Investigator's Meetings and coordinate investigator teams attendance to Investigator Meetings.
• Coordinate and lead CRA and CPA study related activities, perform regular co-monitoring visits with the CRA
• Identify any specific problem related to the study and propose possible solutions in agreement with the RTM
• Monitor study progress: conduct co-monitoring when necessary, review Monitoring Visit Reports, measure gap between planned and actual values (visits, monitored & compiled CRFs, DRFs), alert the project team and make the necessary decisions and actions to solve any study related matter under his/her responsibility
• Participate in internal and external Quality Audits and Inspections, coordinate the responses and ensure the follow-up of corrective measures when necessary.
• Ensure the good management of IP, together with the IP Manager and Monitoring Team
• Ensure timely management of the e/TMF; ensure that International Clinical Development (Clinical Investigations and Clinical Operations) have all necessary information on study progression
• Participate in study-related meetings organized by corporate; maintain professional expertise by attending lectures and conferences
• Contribute to information and training of study monitoring teams
  
  

About You

Education:

• Degree in Health, Life or Natural Sciences or equivalent
  
  

Experience:

• Experience in Clinical Research, as experienced CRA or Project Manager
  
  

Knowledge and technical skills:

• Knowledge of GCP/ICH phase I-IV clinical trials
• Risk Management and Project Management Skills
• Trained for Compliance and Business Integrity
• Data Analytics (& Digital) skills
  
  

Languages:

• high level oral and written fluency in English, Hebrew is a must
  
  

Soft Skills:

• Advanced problem-solving skills and business acumen
• Change management ability
• Advanced interpersonal & relationship management skills
  
  

What We Offer

• An international work environment, focused on continuous learning, enabling performance and providing development systems, structures and tools
• An exciting Play to Win culture, helping us to transform the practice of medicine, and to create an environment where everyone can bring their best version of themselves to work
• Excellent development and career opportunities within the company worldwide, a place where you can grow and make an impact
• An attractive, market competitive compensation & benefits package
• Company car
• Flexible working policy, flexible daily working schedule, and the possibility to work up to 50% of time remotely
• Floating days (we can enjoy longer weekends when national bank holidays occurs on Saturday and/or Sunday)
• Private medical care
• Collective private life and health insurance
• Gender neutral paid parental leave
  
  

If the description fits your experience and has captured your interest, please apply so we can get in contact with you!

Pursue Progress, Discover Extraordinary

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.