Clinical Trial Manager

4 weeks ago

New York, United States BioSpace Full time
Job Details

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"

Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

We are seeking a highly motivated, detail-oriented and results-driven individual to join our company, in the Clinical Operations Department as a Clinical Trial Manager / Senior Clinical Trial Manager who plays an important role in the clinical trial process. As the front-line manager for clinical studies, the CTM is responsible for their quality, timelines, and budget.

Responsibilities:
  • Responsible for the execution of assigned clinical trials. Manages study quality, timelines, and budgets accordingly.
  • Provides operational input to protocol synopses and protocols; solicits input from external parties, including site personnel, vendors, and patient advocacy organizations (as necessary)
  • Leads vendor selection activities (RFP, proposals, meetings, selection, and all associated documentation). Manages vendor contracts and payments. Authors Vendor Oversight Plan and oversees vendor performance.
  • Reviews all operational study plans (project management plan, monitoring plan, communications plan, TMF plan) for assigned clinical trials.
  • Leads site selection activities for assigned trials by review of Site Feasibility Questionnaires and Site Qualification Visit reports. In conduction with Clinical Development, approves sites for participation in a clinical trial.
  • Leads study start-up activities for assigned studies, including site selection, site contracting, and Ethics Committee / Regulatory Authority submissions and approvals. Oversees outsourced start-up activities.
  • Reviews study operational data (e.g., recruitment, data processing, monitoring) to assess study progress. Employs mitigation strategies, as needed.
  • Maintains ClinicalTrials.gov postings
  • Ability to travel as required to carry out responsibilities
  • Perform other tasks as requested by ITI senior management and complete all company and job-related training as assigned within the required timelines.
  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Requirements:
  • Bachelor's degree in a scientific discipline is required; Master's degree preferred
  • 4+ years in Clinical Operations is required; 2+ years as a Clinical Trial Manager
  • CNS experience is required
  • Excellent communication, organizational, and problem-solving skills
  • Strong skills with the Microsoft Office platform (Word, Excel, PowerPoint, and Publisher)
  • Strong attention to detail
  • Ability to effectively multi-task in a dynamic start-up environment
  • Expertise with ICH-GCP guidelines and other clinical trial regulatory requirements
  • Must be able to perform all essential functions of the position, with or without reasonable accommodation

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Clinical Trial Manager/Senior Clinical Trial Manager: Base Salary range $110K - $140K

#ITCI

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