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Senior Clinical Trial Operations Manager

2 months ago

California, United States Meet Full time

Meet the challenges of a dynamic and innovative biopharmaceutical company as a seasoned clinical trial professional. We are dedicated to transforming lives through groundbreaking therapies.

Key Responsibilities:

  • Oversee the planning, implementation, and management of clinical trials from start to finish, ensuring seamless execution and timely delivery.
  • Develop and maintain study protocols, regulatory submissions, and compliance with Good Clinical Practice (GCP) guidelines, fostering a culture of excellence and quality.
  • Collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs, to drive project success and achieve business objectives.
  • Build and maintain relationships with external partners, such as Contract Research Organizations (CROs), investigators, and vendors, to ensure effective communication and coordination.
  • Provide timely and accurate reporting of study results and progress to stakeholders, ensuring transparency and accountability.
  • Identify and mitigate risks to ensure the successful execution of clinical trials, leveraging expertise and resources to overcome challenges.
  • Mentor and guide junior team members, fostering a collaborative and high-performing work environment that promotes growth and development.

Qualifications:

  • Bachelor's degree in a scientific discipline, such as biology, chemistry, or pharmacology.
  • Minimum of 4 years of experience in clinical trial management, with a strong track record of leading Phase I-III trials and delivering results.
  • Comprehensive understanding of clinical trial design, regulatory requirements, and GCP, with expertise in oncology or rare disease clinical trials a plus.
  • Excellent organizational, communication, and leadership skills, with the ability to work effectively in a fast-paced, dynamic environment.
  • Strong problem-solving skills and attention to detail, with the ability to analyze complex data and make informed decisions.