Clinical Project Manager in Argentina with global experience

2 semanas atrás


São Paulo, São Paulo, Brasil Syneos Health Tempo inteiro
Overview

Clinical Project Manager in Argentina with global experience — Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Responsibilities
  • Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
  • Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer's and the Company's contractual agreement.
  • Lead project team to ensure quality, timelines and budget management.
  • Accountable for the financial performance of each project.
  • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
  • Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements.
  • Accountable for all project deliverables for each project assigned. Documentation and Reporting: Responsible for quality and completeness of TMF for assigned projects. Accountable for maintenance of study information on a variety of databases and systems. Responsible for study management components of inspection readiness for all aspects of the study conduct. Oversight for development and implementation of project plans. Plan, coordinate and present at internal and external meetings. Prepare project management reports for clients and management. Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
  • Develops strong relationships with current clients to generate new and/or add-on business for the future.
  • May participate in bid defense meetings where presented as potential project manager. May be required to line manage other project management team members and clinical monitoring staff.
Qualifications
  • Bachelor's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
  • CRO and relevant therapeutic experience preferred. Strong knowledge of GCP/ICH guidelines and regulatory requirements.
  • Strong organizational skills. Ability to manage time and work independently. Direct therapeutic area expertise. Ability to embrace new technologies. Excellent communication, presentation, interpersonal skills, both written and spoken. Ability to travel approximately 25%.
Additional Information

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Project Management and Information Technology
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