Clinical Trial Manager

BBBH36021_1715967159
  • San Diego, California
  • Permanent

Job Title: Clinical Trial Manager - Rare Disease

Location: San Diego, CA (Hybrid working model, remote candidates with exceptional qualifications may be considered)

Overview:

Lead the planning, execution and management of clinical trials for innovative rare disease treatments at a small biotechnology company with a collaborative culture. Leverage expertise in patient recruitment, site management and cross-functional collaboration to drive successful study completion. Ensure adherence to GCP, regulatory requirements and company policies across all trial phases. This client is looking for a consultative individual who enjoys working in a close-knit team with a healthy work environment.

Strategic Responsibilities:

  • Develop comprehensive clinical trial plans encompassing timelines, budgets and resource allocation
  • Establish robust patient recruitment strategies and initiatives to meet enrollment targets
  • Foster collaborative relationships with clinical sites, physicians and patient advocacy groups
  • Represent the company at relevant industry events and conferences

Operational Responsibilities:

  • Oversee end-to-end execution of rare disease clinical trials (Phase I-IV) per protocols
  • Coordinate closely with internal teams (medical, regulatory, data management) and external partners
  • Implement quality systems and processes tailored to complex rare disease studies
  • Ensure timely collection, entry and reporting of clinical data adhering to GCP
  • Manage clinical documentation, site monitoring activities and regulatory submissions
  • Identify risks, deviations and implement corrective/preventive actions

Leadership:

  • Lead and mentor a team of clinical operations professionals
  • Promote continuous learning and development in rare disease clinical practices
  • Attract, develop and retain top talent with rare disease experience

Qualifications:

  • Bachelor's degree in life sciences or healthcare field (advanced degree preferred)
  • 5+ years of progressive clinical trial management experience in rare diseases
  • Demonstrated success in patient recruitment and enrollment for rare disease studies
  • Deep understanding of GCP, regulatory guidelines and evolving rare disease landscape
  • Proven track record managing domestic and global rare disease clinical trials
  • Exceptional project management, problem-solving and stakeholder management skills
  • Collaborative approach with ability to build cross-functional partnerships

This key leadership role will spearhead clinical trials for transformative rare disease therapies at a small biotech with a collaborative culture. Extensive rare disease expertise spanning study operations, patient engagement and regulatory compliance is critical. The ideal candidate will be a consultative professional who thrives in a close-knit team environment.

Nicole Crowley Senior Consultant

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