Lead Clinical Trial Manager

2 weeks ago

Foster City, California, United States Vakulatech Full time
Position Overview

Job Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical Operations

Company: Vakulatech

Role Duration: 6 months

Compensation: $45-$50/hr W2

Visa Requirements: Open to all visa types except H1B

Overview: The Clinical Operations team is pivotal in executing Phase I to IV clinical trials across various therapeutic areas. This role is essential in ensuring compliance with standard operating procedures (SOPs), company policies, and regulatory guidelines, thereby delivering high-quality clinical data that supports the global registration and commercialization of products.

Key Responsibilities:

  • Oversee or manage segments of Phase I, II, or III clinical studies.
  • Collaborate with Biomarker Sciences, Clinical Virology, and Clinical Pharmacology in vendor selection and manage all vendor interactions and deliverables.
  • Act as the operational liaison for client studies.
  • Plan and coordinate operational activities related to the collection, delivery, and analysis of biological samples within clinical trials.
  • Manage study timelines, documentation, and communications effectively.
  • Serve as the primary contact for internal and external stakeholders to ensure successful implementation of biological sample analysis strategies.
  • Facilitate project meetings and conference calls with CROs, vendors, and cross-functional teams.
  • Engage in the functional review of study protocols and related documents.
  • Contribute to the development of SOPs and participate in special projects.
  • Develop tools and processes to enhance project efficiency and effectiveness.
  • Identify potential operational challenges proactively and collaborate with stakeholders to devise solutions, ensuring studies remain on track.
  • Ensure compliance with established practices, policies, and regulatory requirements.

Qualifications:

We value diverse contributions that enhance our mission to serve patients. The following qualifications and skills are sought for this role:

  • Advanced degree (MA/MS/PharmD/PhD) with a minimum of 2 years of relevant clinical or related experience in life sciences, or a bachelor's degree (BA/BS/RN) with at least 4 years of relevant experience.
  • Experience managing external vendors.
  • Proficiency in Clinical Trial Management Associate (CTMA) grade 25 requirements.

Knowledge and Skills:

  • Ability to learn quickly and adapt to changing environments.
  • Knowledge of full-cycle clinical study management from initiation to closure.
  • Comprehensive understanding of FDA and EMA regulations, ICH guidelines, GCP, and Clinical Operations principles.
  • Familiarity with medical and scientific terminology.
  • Strong communication skills, both verbal and written.
  • Ability to thrive in a team-oriented, matrixed environment.
  • Capability to manage multiple tasks efficiently.
  • Willingness to travel as necessary.

Essential Skills: Sample management experience, strong Microsoft Office skills, excellent communication abilities.

Preferred Skills: Experience in clinical operations or bioanalytical operations, laboratory (bench) experience.

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