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Senior Clinical Trial Management Specialist

2 months ago

Foster City, California, United States Integrated Resources, Inc Full time
Job OverviewPosition Title: Senior Clinical Trial Management Specialist
Location: Remote
Contract Duration: 06+ months

Compensation: $60 - $64/hr. on W2

Position Summary:
As a Senior Clinical Trial Management Specialist, you will play a pivotal role in the execution of clinical trials across various phases, ensuring adherence to established protocols and regulatory standards. Your contributions will be essential in delivering high-quality clinical data that supports the development and commercialization of innovative products.

Key Responsibilities:
  • Oversee and manage components of Phase I, II, or III clinical studies.
  • Collaborate with Biomarker Sciences, Clinical Virology, and Clinical Pharmacology in vendor selection and manage all interactions and deliverables.
  • Act as the operational liaison for clinical studies.
  • Coordinate all operational activities related to the collection, delivery, and analysis of biological samples within clinical trials.
  • Manage timelines and documentation to ensure effective communication among stakeholders.
  • Facilitate project meetings and conference calls with CROs and cross-functional teams.
  • Contribute to the review of study protocols and related documents.
  • Assist in the development and approval of informed consent forms.
  • Engage in the development of standard operating procedures and special projects.
  • Identify operational challenges and collaborate with stakeholders to implement solutions.
  • Ensure compliance with established practices, policies, and regulatory requirements.

Qualifications:
We value diverse backgrounds and experiences. The following qualifications are preferred for this role:

Education & Experience:
  • MA/MS/PharmD/PhD with 2+ years of relevant clinical experience.
  • BA/BS/RN with 4+ years of relevant clinical experience.
  • Experience managing external vendors.
  • Proven proficiency in Clinical Trial Management Associate responsibilities.

Knowledge & Skills:
  • Ability to learn quickly and adapt to changing environments.
  • Comprehensive understanding of full-cycle clinical study management.
  • In-depth knowledge of FDA, EMA regulations, ICH guidelines, and GCP principles.
  • Familiarity with medical and scientific terminology.
  • Strong communication skills and ability to work in a team-oriented environment.
  • Capability to manage multiple tasks effectively.
  • Willingness to travel when necessary.

Essential Skills:
  • Experience in sample management.
  • Proficient in Microsoft Office applications.
  • Excellent communication abilities.

Preferred Skills:
  • Experience in clinical operations or bioanalytical operations.
  • Laboratory experience.

Unique Opportunity:
This role offers the chance to collaborate with a diverse and cross-functional team, enhancing your professional growth and expertise in clinical operations.