Clinical Trial Manager (Remote & Full-Time)

About Granata BioGranata Bio is a biopharma company working to shape the future of reproductive health by reimagining what’s possible to help build families. Founded in 2018, we are dedicated to developing and accelerating fertility treatments that expand therapeutic choices and improve access and affordability. Our people are passion-driven reproductive health experts who understand that innovation never stands still, and neither do we. Each day, we roll up our sleeves and put in the work to move one step closer to unlocking new possibilities for fertility patients and their care teams. Our ideal teammates show up in big ways by embracing productivity, authenticity, and the courage to drive innovation. Primary RoleThe Clinical Trial Manager (CTM) is responsible for the project management and operational oversight of assigned clinical trials from study start-up through close-out. This includes managing cross-functional teams, CROs, vendors, clinical sites, and investigational product (IP) logistics to ensure timely, compliant, and high-quality study execution in accordance with the protocol, GCP/ICH guidelines, and applicable regulations. Key ResponsibilitiesServe as the primary point of contact for internal teams, CROs, and vendors on all aspects of trial execution.Ensure overall project timelines, milestones, quality metrics, and budget targets are met.Manage clinical site operations, including site selection, activation, performance tracking, and close-out.Manage Trial Master File (TMF) completeness, accuracy, and timely document QC.Review and track CRO deliverables, including: Monitoring visit reports, Protocol deviations and violations, Recruitment updates, and site performance metrics.Escalate risks or operational issues to the Head of Scientific Affairs, providing mitigation strategies and follow-up.Support protocol amendments, deviation assessment, issue resolution, and communication across functions.Contribute to data review, cleaning oversight, and the drafting of the Clinical Study Report (CSR).Ensure compliance with internal SOPs, GCP, and inspection readiness standards. Project Management ActivitiesDevelop and maintain detailed project plans, risk logs, trackers (e.g., enrollment, supply, deviations), and timelines.Coordinate regular cross-functional team meetings, tracking action items and progress. Site Management ResponsibilitiesSite management in collaboration with CROs figures: -Site feasibility and selection -Site initiation and training -Enrollment tracking and performance monitoring -Protocol compliance and data quality -Close-out planning and executionMaintain awareness of site-level challenges, proactively identify risk factors, and support resolution.Support to sites for any kind of questions they may have. Vendor OversightServe as the point of contact and operational lead for third-party vendors, including: CROs, Central laboratories, IXRS/IRT providers, eCOA/ePRO vendors, and Imaging or specialty labs.Oversee vendor adherence to scope of work, deliverables, and timelines.Ensure vendor metrics and performance reports are reviewed and acted upon.Coordinate issue escalation, root cause analysis, and implementation of corrective actions when needed. Investigational Product (IP) Management and AccountabilityEnsure proper oversight of IP logistics in collaboration with clinical supply, CROs, IXRS/IRT vendors, and study sites.Monitor IP inventory levels, shipment timelines, storage conditions, and reconciliation across all participating sites.Review site and vendor documentation related to IP accountability, temperature excursions, and destruction.Coordinate resolution of any discrepancies in drug accountability and ensure documentation is audit-ready.Support inspection readiness by ensuring all IP-related documentation is maintained and consistent with GCP and internal procedures. QualificationsBachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).Minimum 4 years of clinical trial experience, with at least 2 years as a Clinical Trial Manager or in a project management role.Demonstrated experience managing vendors, CROs, and global clinical sites across Phase I–III studies.Strong working knowledge of ICH-GCP, FDA/EU regulatory requirements, clinical operations DepartmentClinical Operations Reports toHead of Scientific Affairs