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Manager, Clinical Operations

4 months ago

North Brunswick, United States ADLAI NORTYE USA INC Full time
Job DescriptionJob Description

Company Overview:

We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work.


Position Overview:

The Clinical Trial Manager of Clinical Operations is responsible for supporting and planning, budgeting, directing, and evaluating clinical trials under GCP and ICH regulations. This position will lead and support clinical trial(s) operations and study teams, including cross-functional coordination, CRO and vendor management to deliver high quality studies on time and budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements, and Adlai Nortye’s standard operating procedures.

Key Responsibilities:

  • Manage all aspects of clinical study progress from start-up to close-out activities and end of study reporting. Including preparing and approving detailed project plan(s) with cross-functional input for all phases of the clinical study assuring adherence to intended timelines in order to achieve study goals while ensuring compliance with GCP guidelines/regulations and SOPs,
  • Oversee and manage CRO and clinical vendors to ensure successful conduct of the clinical trial and to ensure data integrity and study data and execution quality. Identifying risks, and implementing risk mitigation plans where appropriate.
  • Generate/track all protocol contracts/budgets and analyze budgets, as they relate to cross-functional areas with timely escalation of all budget issues to finance and executive management.
  • Serve as liaison between Sponsor, CRO and clinical sites to maintain communication and to support study delivery on time and on budget.


Qualifications:

  • 2-5 years project management experience & clinical operations (or equivalent combination of experience/training.
  • General knowledge and understanding of the clinical development lifecycle for Phase I-III clinical operations.
  • In depth knowledge of Knowledge of GCPs and ICH guidelines
  • Experience working with third party contract research, development, and/or laboratory organizations.
  • Computer skills, including MS Office
  • Strong customer service skills


Travel:

  • Ability to travel domestic and internationally 20%.

Benefits:

Competitive salary commensurate with experience

Comprehensive benefits package, including medical, dental, and vision coverage

Opportunities for career growth and professional development

Collaborative and dynamic work environment with a diverse team of scientists and clinicians

Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research