Clinical Project Leader | BioNJ Talent Services

Clinical Project Leader

Contact Information
Contact Name: 
Sanofi
Organization Name: 
Sanofi
Position Location: 
Bridgewater, NJ
Company Profile: 

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions, consumer healthcare, established prescription products and generics. More than 100,000 people at Sanofi are dedicated to making a difference in patients’ daily lives, wherever they live, and enabling them to enjoy a healthier life.

Job Description:

The primary role of the Clinical Project Leader (CPL) is to act as the key operational interface with internal and external services to develop, implement, maintain and improve operational processes for clinical trial conduct. This position supports the CSU Clinical Investigators, medical advisor (MA), in the conduct and management of clinical trials, oversees in-house Clinical Project Assistants (CPA’s), and oversees activities of CRA’s for clinical trials with awareness of related functions and roles. Significant operational planning and analysis is required.
Major Duties and Responsibilities:
Responsible for the overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).
Interface with corporate CTOMs, CRA Team, MAs and CSDs for operational input for feasibility, trial design/methodology, standard medical practice and data capture
Develop and manage the trial budget. Overall responsibility for negotiation of financial aspects of clinical trial.
Collaborate with medical function in the safety evaluation of study subjects in ongoing trials.
Ensure all aspects of study site management i.e. recruitment of qualified investigators, site initiations, conduct investigator meetings, ensure enrollment criteria are met and other aspects of the study management as appropriate.
Responsible for mentoring and team cohesion. CPL mentoring as needed
Facilitate development of study tools and appropriate tracking systems for coordination of trials, grants, enrollment status and clinical supplies. Ensures adherence to contractual obligations of local vendor relative to the service provided, as appropriate. Contribute to operational details in specifications for local vendor contracts, as needed.
This position can be remote.

Qualifications: 

Required Education/Qualifications:
Bachelor’s degree and 8+ years of clinical research experience; 1-2 years of field monitoring experience; prior demonstration of an ability to manage people and projects.
Working knowledge of clinical study development, FDA regulations and ICH/GCP guidelines.
Operational planning experience.
Excellent interpersonal and communication skills (verbal and written), including proficiency in medical terminology.
Professional demeanor with ability to interact effectively with scientists and managers from multiple disciplines; serves to provide internal operational expertise on assigned area and liaise with external organizations specific to clinical trial.
Strong organizational and time management skills. Self-motivation and attention to detail.
Sanofi US Services, 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.
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Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Research
Paid: 
Yes