Clinical Project Leader
Bridgewater, New Jersey,
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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.
Major Duties & Responsibilities:
Lead project(s) within the US CSU from operational feasibility to archiving with support (i.e. from mentors, SMEs, Clinical Research Operation Managers (CROMs), Therapeutic Area (TA) specialists, etc.).
Manage studies with simple or small number of vendors (i.e. 0-2).
Lead risk assessment, develop contingency planning and risk-mitigation strategies at the project level.
Mentor other CPLs on role and responsibility of CPL.
Share lessons learned and best practices.
Lead or participate in US CSU Workstreams.
Represent Sanofi at external Scientific Conferences.
Mentor CPLs to the role at Sanofi.
Serve as Subject Matter Expert (SME).
Represent the US CSU with cross-functional leadership.
Lead initiatives and influence improvements within the US CSU.
Knowledge and Skills:
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.
At least 5 years of experience in clinical research.
Bachelor's Degree in scientific discipline or equivalent RN.
Knowledge and Skills Desirable But Not Essential:
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.
Working autonomously consistently.
Major Challenges and Problems:
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 Internal & External Relationships:
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.
Decision Making Authority:
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.
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