Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives.
Calico is seeking a Senior 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.
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
BA/BS degree required with a minimum of 7+ years of clinical research experience including 3+ 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
Must be willing to work onsite at least three days per week
Calico requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Calico will consider requests for Reasonable Accommodations.