Clinical Trial Management Associate

Actalent • Foster City, CA

410d • $104,000 - $110,926 • Hybrid

About The Position

The Clinical Trial Management Associate will support the Clinical Operations team in the execution of Phase I - IV clinical trials across various therapeutic areas. This role involves managing components of clinical studies, coordinating with vendors, and ensuring compliance with regulatory guidelines to deliver high-quality clinical data for product registration and commercialization.

Requirements

• Experience in clinical operations and sample management.
• Proficiency in Microsoft Office.
• MA/MS/PharmD/PhD with 2+ years of relevant clinical or related experience in life sciences, or BA/BS with 4+ years of relevant clinical or related experience in life sciences.
• Experience in managing the work of external vendors.
• Demonstrated ability to be a fast learner.
• Ability to be flexible and adaptable to change.
• Knowledge of full cycle clinical study management, from start-up to close-out.
• Significant industry knowledge.
• Complete knowledge of FDA and EMA regulations, ICH guidelines, GCP, and key Clinical Operations principles, concepts, practices, standards, processes, and tools.
• Familiarity with standard medical/scientific terminology.
• Ability to communicate clearly and concisely.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.

Nice To Haves

• Ability to travel when needed.

Responsibilities

• Lead or manage components of Phase I, II, or III studies.
• Assist Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinate all interactions and deliverables from vendors.
• Serve as operational contact for studies.
• Plan and coordinate all operational activities required for the collection, delivery, and analysis of biological samples within a clinical trial.
• Manage study timelines, including documentation and communications.
• Serve as the point of contact with internal and external stakeholders for successful implementation of all biological sample analysis strategies in programs.
• Participate in and manage project meetings and conference calls with CROs, other vendors, and cross-functional teams.
• Participate in the functional review of study protocols and other study-related documents such as clinical sample management plans, study communication plans, or presentations for Investigator and/or Study Kick-Off meetings.
• Review and approve main study and optional informed consents, and review additional study-specific informed consents.
• Contribute to SOP development and participate in special projects.
• Develop tools and processes that optimize project efficiencies and effectiveness.
• Proactively identify potential operational challenges and collaborate with key stakeholders to provide solutions to ensure study execution remains on track to projected budgets and timelines.
• Ensure own work complies with established practices, policies, processes, and any regulatory or other requirements.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees