Clinical Research Operations Manager

2 weeks ago

San Diego, California, United States Arthrosi Therapeutics Inc Full time
Job Overview

Salary: $130,000 - $150,000

POSITION SUMMARY

The full-time Clinical Trial Manager will play a crucial role within the ClinOps team, contributing to the advancement of the company's clinical development initiatives. The ideal candidate will be proactive, adaptable to a dynamic start-up atmosphere, and possess a creative mindset. A solid background in managing Phase I - III clinical trials, along with a comprehensive understanding of clinical operations, ICH/GCP, and FDA regulatory standards, is essential. The Clinical Trial Manager will oversee all clinical components of assigned studies, showcasing expertise in effective project management, financial oversight, and vendor relations.

KEY RESPONSIBILITIES

  • Supervise and facilitate the execution of assigned clinical trials, ensuring compliance with Good Clinical Practices (GCP) and relevant regulatory guidelines.
  • Collaborate with a multidisciplinary team in a fast-paced environment to guarantee that clinical trials are completed on schedule and within budget, adhering to applicable GCP/ICH standards and company protocols.
  • Assist in the identification, assessment, selection, and management of clinical trial sites and vendors.
  • Engage professionally with study sites and vendors to ensure seamless trial execution.
  • Provide regular updates on study progress to senior management and stakeholders; proactively identify and address issues that may arise during the trial.
  • Oversee the timely recruitment of trial participants and ensure efficient data management.
  • Manage selected study vendors, ensuring they meet established program milestones within budget and timeline constraints.
  • Support the creation of study-related documents and tools, including protocols, consent forms, project plans, budgets, and other necessary materials.
  • Ensure the implementation and maintenance of the Trial Master File for inspection readiness.
  • Recommend and apply innovative strategies to enhance clinical trial management and outcomes, including contingency planning.
  • Conduct ongoing data reviews and cleaning activities.
  • Evaluate clinical study plans, reports, and metrics.
  • Participate in feasibility assessments and the selection of countries and sites for study execution.
  • Contribute to the development and delivery of study-specific training during investigator meetings and other relevant sessions.

ADDITIONAL RESPONSIBILITIES

Responsible for tracking ancillary and investigational supplies, specimens, and imaging.

QUALIFICATIONS

  • Bachelor's degree (or equivalent) in a relevant scientific discipline is preferred.
  • A minimum of 2 years of experience in clinical trials, including management and monitoring within pharmaceutical, biotech, or CRO environments; experience in oncology studies is a plus.
  • Experience with Phase I-III clinical trials, including global exposure.
  • In-depth knowledge of drug development processes and clinical operations in accordance with ICH/GCP and other regulatory guidelines.
  • Proficient in MS Office applications, including Word, Excel, SharePoint, and PowerPoint.

SKILLS AND ATTRIBUTES

  • Comprehensive understanding of drug development and clinical operation processes in line with ICH/GCP guidelines.
  • Strong proficiency in MS Office applications.
  • Ability to identify needs, devise solutions, and take initiative proactively.
  • Exceptional organizational and time management skills.
  • Excellent verbal and written communication abilities.
  • Proven team player with a successful track record in cross-functional collaboration within a fast-paced environment.
  • Demonstrated capacity to work effectively with internal teams and external partners.

WORKING CONDITIONS

Office-based environment with potential domestic and international travel up to 25%.

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