Clinical Trial Leader / Associate Clinical Trial Leader

Calico is seeking a Clinical Trial Leader that will be responsible for supporting and/or leading the study management team in the execution of clinical trials to maintain regulatory compliance and ensuring quality, integrity and timely delivery of the clinical data. The individual will provide operational support to one or more clinical studies under the direction of the Clinical Operations program lead or Study Management Team lead. The successful candidate will be responsible for collaborative oversight of cross-functional study team activities, as well as communication with external vendors and stakeholders (e.g., CROs, central labs, IRBs/ECs, and other partners) while contributing to a positive and collaborative team environment.

Key Responsibilities:

• Assists or leads select activities in support of clinical research protocols from protocol design to final deliverables, in accordance with specified timelines and budgets
• Liaises with CROs and other clinical vendors as directed to ensure deliverables are met on time and within budget.  Provides information and resolution for specific study requests and issues and escalates as needed
• Provides oversight of site management and select study vendors in alignment with oversight plans and through reviews of reports and tracking metrics and deliverables. Identifies and implements risk mitigation strategies or corrective action plans while escalating as appropriate
• Assists or leads the development and review of study documents, including protocols, ICFs, CRFs, operational or study reference documents, study newsletters, site materials, and other study related documents
• Tracking and managing study and vendor budgets, including invoice review, PO management/reconciliation, as well as review of site-specific study budgets
• Develops facility with data management software as required in order to review clinical data and associated metrics, and addressing data quality issues directly as needed
• Ability to travel approximately 20% depending on program needs

Candidate Requirements:

• BA/BS degree required with a minimum of 5 years of clinical research experience including 2 years in an industry setting
• Thorough understanding of ICH GCP guidance, FDA and EMA regulations
• Effective organization skills with a passion for delivering quality results
• Able to work independently, escalate issues appropriately, and to ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality
• Strong interpersonal skills to build and maintain positive working relationships
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to “roll up sleeves” in a start-up environment
• A positive can-do attitude