Clinical Research Project Leader

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 pivotal role within the ClinOps team, contributing significantly to the achievement of key objectives in the Arthrosi clinical development initiatives. The ideal candidate will possess a self-driven attitude, thrive in a dynamic start-up atmosphere, and demonstrate flexibility and creativity. A solid background in managing Phase I to III clinical trials, along with a comprehensive understanding of clinical operations, ICH/GCP standards, and FDA regulatory frameworks, is essential. The Clinical Trial Manager will oversee all clinical facets of designated studies, showcasing expertise in effective project management, financial oversight, and vendor relations.

KEY RESPONSIBILITIES

  • Supervise and ensure the execution of assigned clinical trials and related activities in compliance with Good Clinical Practices (GCP) and pertinent national and international regulations.
  • Collaborate closely with a multidisciplinary team in a fast-paced, growth-oriented environment to guarantee that clinical trials are completed on schedule and within budget, adhering to applicable GCP/ICH guidelines, regulatory standards, and Arthrosi Standard Operating Procedures (SOPs).
  • Assist in the identification, assessment, selection, and management of clinical trial sites and vendors.
  • Engage professionally and effectively with participating study sites and vendors to facilitate seamless study operations.
  • Provide regular updates on study progress to senior management and other stakeholders; proactively identify and address issues that arise during the study; manage the escalation of study-related challenges.
  • Ensure timely recruitment of trial participants while maintaining efficient and effective data management.
  • Oversee selected study vendors, ensuring they meet established program milestones within budget and timeline constraints.
  • Aid in the development of study documentation and tools, including protocols, consent forms, project plans, budgets, logs, templates, newsletters, and other necessary documents.
  • Ensure the implementation and oversight of the Trial Master File to maintain inspection readiness.
  • Propose and execute innovative processes to enhance clinical trial management and deliverables, including contingency strategies.
  • Conduct ongoing data reviews and data 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 creation and delivery of study-specific training during investigator meetings, CRA training, and other relevant sessions.

QUALIFICATIONS

Education, Certifications, Experience

  • A 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 in pharmaceutical, biotech, or CRO environments; experience in oncology studies is advantageous.
  • Familiarity with Phase I-III clinical trials, including global experience.
  • Comprehensive knowledge of drug development and clinical operation processes in accordance with ICH/GCP and other regulatory guidelines.
  • Proficiency in MS Office applications, including Word, Excel, SharePoint, and PowerPoint.

Knowledge, Skills, and Abilities

  • In-depth understanding of drug development and clinical operation processes as per ICH/GCP and other regulatory guidelines.
  • Proficient in MS Office applications, including Word, Excel, SharePoint, and PowerPoint.
  • Ability to identify needs, devise solutions, and take initiative proactively.
  • Strong organizational and time management capabilities.
  • Excellent verbal and written communication skills.
  • Proven ability to work effectively as part of a team in a cross-functional and fast-paced environment.
  • Demonstrated capacity to collaborate effectively with internal teams and external partners.

SPECIAL WORKING CONDITIONS

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

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