Project Manager

Job Description

• The Global Feasibility Lead is accountable for the coordination and conduct of the requisite assessments associated with determining the feasibility and operational implications of clinical trials proposed or to be performed by the Clinical & Sciences Operation Platform (CSO) of Company’s R&D. 

• The objective of the feasibility assessment is to develop recommendations utilizing wide sources of data to support protocol development and overall ability to conduct the study in a manner conducive to patient recruitment/ participation within study milestone dates. 

• Protocol optimization and the ability to influence decision makers towards inclusion/ exclusion criteria, study procedures, PRO and patient friendly data collection modalities. Ensuring that all relevant personnel are anticipating the challenges facing development programs, the Global Feasibility Lead is responsible for the operational communication of the Phase I-IV Client's portfolio across the operational platform. 

• Responsible for identifying risks associated with internal competition and proposing risk mitigation strategies to positively support all programs. The Global Feasibility Lead is also accountable for identifying protocol specific nuances to be considered when developing robust recruitment and retention strategies to enable patient participation in the study. These high level considerations will be the responsibility of Trial Operations and CSU personnel to refine for central, local and site specific recruitment plans.   

• He/she will work in very close collaboration with the Business Units, CSO Project Leaders, Clinical Study Directors, Clinical Study Unit leadership, Medical Advisors, Investigator and Patient Network team and Trial Operations and the Competitive Intelligence 

• Lead to ensure all key stakeholders are equipped with the ability to anticipate the needs of upcoming studies and act as the central point of coordination to establish scenarios for the platform to evaluate when determining the operational strategy. Coordination of communication activities related to the portfolio is a key responsibility of the group as well as ongoing business unit/ CSO team training on lessons learned from previous studies. 

• Working in collaboration with various stakeholders, the Global Feasibility Lead will establish the operational recommendations stemming from the strategic priorities that impact the near term and long term priorities of Client's development program.s Alignment with Medical Affairs for global strategic study placement decisions is also expected for phase 3 programs. To better serve some customers experience or qualification in a medical/ health sciences specialization will be required. SCOPE: All Phase 2b- IV clinical studies or projects related to clinical development (including at times, patient focused Phase 1-2a Clinical & Exploratory Pharmacology studies). 

• The Global Feasibility Lead initiates activities prior to the pre-assessment kick off and completes their activities once a study has conducted a retrospective review of operational effectiveness, typically occurring at LPO. Demonstrated expertise in: Coordinating and leading large, multi-departmental teams Team leadership that promotes fact based decision making Proactive planning Exquisite communication Critical thinking & problem solving Change management 

• Strong Proficiency in Powerpoint, Excel, Sanofi internal systems & public speaking Strong Consumer Focus and industry knowledge Key Qualities: Initiative, Commitment to Excellence, Resourcefulness, Persuasive, Accountable and Collaborative Ability to Influence and Align Cross Functional Team Members to Achieve a Higher Business Result within a Matrix Organization Excellent Problem Solving, 

• Analytical and Quantitative Skills Proven Thought Leadership Capabilities, Creative Thinking Skills and Ability to Drive Change Ability to Manage Multiple Projects Simultaneously The candidate must be proficient in English, be able to travel up to 25% and be able to accommodate flexible working hours outside of the traditional 9-5 day. Required soft skills: excellent communicator, effective presentation skills, good interpersonal skills, ability to quickly build relationships and trust

Qualifications

Demonstrated expertise in: 

• Coordinating and leading large, multi-departmental teams 

• Team leadership that promotes fact based decision making 

• Proactive planning 

• Exquisite communication 

• Critical thinking & problem solving 

• Change management 

• Strong Proficiency in Powerpoint, Excel, Client's internal systems & public speaking 

• Strong Consumer Focus and industry knowledge Key Qualities: 

• Initiative, Commitment to Excellence, Resourcefulness, Persuasive, Accountable and Collaborative 

• Ability to Influence and Align Cross Functional Team Members to Achieve a Higher Business Result within a Matrix Organization 

• Excellent Problem Solving, Analytical and Quantitative Skills 

• Proven Thought Leadership Capabilities, Creative Thinking Skills and Ability to Drive Change 

• Ability to Manage Multiple Projects Simultaneously The candidate must be proficient in English, be able to travel up to 25% and be able to accommodate flexible working hours outside of the traditional 9-5 day. 

• Required soft skills: excellent communicator, effective presentation skills, good interpersonal skills, ability to quickly build relationships and trust. 
•  Education At least a Master's level degree in Health Care related field or Pharmacology related sciences 
• Experience: • Minimum of 10 years experience within the Pharmaceutical industry with a strong emphasis in clinical trial operations and / or protocol design 
•  Experience in Clinical Development, especially relevant experience in multinational study management in a medical specialization would be appreciated. Knowledge in ICH, GCP and local regulations. 
•  Knowledge in Epidemiology , Project & Data Management, Clinical Site Management is strongly desired Fluent in English  

Additional Information

For more information, Please contact:

Sneha Shrivastava

973 967 3348