Clinical Trial Manager

4 weeks ago

San Diego, United States i-Pharm Consulting Full time

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.

Desired Skills and Experience

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.

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