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Lead Clinical Trial Operations Manager
2 months ago
Job Title: Senior Clinical Trial Manager - Biomarker and Bioanalytical Operations
Company: Vakulatech
Job Duration: 6 months
Compensation: $45-$50/hr W2
Visa Requirements: Acceptable for all visa types except H1B
Role Summary:
The Clinical Operations department is tasked with the global execution of all phases of clinical trials across various therapeutic areas. This team plays a pivotal role in ensuring that all clinical studies adhere to established SOPs, corporate policies, and regulatory standards, thereby delivering timely and high-quality clinical data that supports the global registration and commercialization of products.
Key Responsibilities:
- Oversee or manage specific components 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 contact for client studies as needed.
- Plan and coordinate all 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.
- Participate in and facilitate project meetings and conference calls with CROs, vendors, and cross-functional teams.
- Contribute to the functional review of study protocols and related documents, including clinical sample management plans and communication strategies.
- Assist in the review and approval of informed consent documents.
- Engage in SOP development and participate in special projects as necessary.
- Develop tools and processes aimed at optimizing project efficiency and effectiveness.
- Identify potential operational challenges proactively and collaborate with stakeholders to devise solutions, ensuring that study execution aligns with projected budgets and timelines.
- Ensure compliance with established practices, policies, and regulatory requirements in all work activities.
Qualifications:
We value diverse backgrounds and experiences. 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 vendor relationships.
- Proven proficiency meeting the requirements for the Clinical Trial Management Associate (CTMA) grade 25 position.
Knowledge and Skills:
- Ability to learn quickly and adapt to changing circumstances.
- Comprehensive understanding of full-cycle clinical study management, from initiation to closure, with a track record of achieving targeted outcomes.
- Extensive industry knowledge, including familiarity with FDA and EMA regulations, ICH guidelines, GCP, and key Clinical Operations principles.
- Strong communication skills and the ability to work effectively in a team-oriented, matrixed environment.
- Capability to manage multiple tasks simultaneously and travel as required.
Preferred Skills:
- Experience in clinical operations or bioanalytical operations.
- Laboratory (bench) experience is a plus.
