Sanofi Group Clinical Project Leader in United States
The Clinical Project Leader (CPL) is accountable for the execution of assigned clinical trials from feasibility to closeout at the United States Clinical Study Unit (US CSU) level (supporting the Global Study Team). Accountabilities include but are not limited to study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives. The CPL acts as the key operational interface with internal and external stakeholders to develop, implement, maintain and improve operational processes for clinical trial conduct. The CPL oversees at a project level the Clinical Project Assistants (CPAs) and Clinical Research Associates (CRAs) with awareness of related functions and roles.
KNOWLEDGE , SKILL , FORMA L E DU C AT I ON & EXP E RIE N C E R E QU I R EMENT S
Knowledg e and Skil ls:
Demonstrated knowledge of clinical development
Experience participating in and organizing CRA training and Investigator Meetings
Risk identification, mitigation and escalation / issue management and escalation
Problem-solving & decision making
Interpersonal/Communication skills (written and verbal)-including proficiency in medical terminology
Attention to detail
Technical proficiency in trial management systems
Technical proficiency in Microsoft Office applications
Ability to embrace new technologies
Knowledge of ICH/GP and regulatory guidelines and directives
Fo r ma l Educat i on and Experie n c e Requi r ed:
Bachelor's Degree in scientific discipline or equivalent RN
At least 5 years of experience in clinical trials
Knowledg e and Skil l s Desi r ab l e Bu t No t Essent i a l:
At least 2 years pharmaceutical project management experience
At least 1-year field monitoring or site coordinator experience
Cross-functional leadership & stakeholder management
Ability to understand & implement strategic direction and guidance for respective clinical trials
Effective team management
Influence and negotiation
Majo r Challenges :
Study start-up, implementation of protocol amendments, shifts in study timelines, recruitment and retention challenges, data management and vendor related issues can occur. Effective and proactive communication with various stakeholders can help successfully navigate these.
Key I n t ernal a n d Exter n al Relat i onsh i ps:
Clinical Research Operations Manager (CROM)-Project level updates, issue escalation, performance review and professional development-individualized
Clinical Project Leaders (CPL)-Partnering with assigned co-CPLs or with CPLs across the US CSU for best practice sharing, knowledge transfer-as needed
Global Study Manager (GSM) or Regional Study Manager (RSM)-Project related communications to support global study execution-as indicated
Medical Advisor (MDA)-Medical related support of study and sites, training-as needed
Clinical Research Associate (CRA)-Project related monitoring-as needed
Clinical Project Associate (CPA)-Administrative project support-as needed
Medical Science Liaison (MSL)-field insights, site specific support as indicated by CSU
Decis i o n M a ki n g Aut h ority :
- Project related decisions such as site selection, recruitment and retention, budget, and risk management planning at the country and site level.
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.
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.