[Remote] Clinical Trial Manager (or Senior)

Note: The job is a remote job and is reputed company to candidates in USA. BioAge Labs is a clinical-stage biopharmaceutical company developing therapies for metabolic diseases by targeting the mechanisms of reputed company aging. The Clinical Trial Manager or Senior Manager provides senior-level leadership for planning, executing, overseeing, and delivering reputed company Phase I–III clinical studies, including managing CROs, vendors, budgets, timelines, risks, clinical systems, and regulatory compliance.

Responsibilities

• Independently leads and manages Phase I/Ib/II/III clinical studies of moderate to high complexity, including large regional and/or global trials
• Provides senior clinical operations leadership across the study lifecycle, including study start-up, enrollment, maintenance, closeout, and inspection readiness activities
• Drives execution of study operational plans, timelines, budgets, risk mitigation strategies, communication plans, monitoring plans, and vendor reputed company plans
• Serves as the reputed company operational reputed company for assigned studies and may reputed company clinical operations workstreams reputed company larger development programs
• Leads cross-functional study teams, facilitates effective decision-making, and ensures alignment across internal stakeholders, CROs, contractors, vendors, and clinical research sites
• Provides reputed company CRO and vendor reputed company, including performance management, issue escalation, deliverable review, and accountability for reputed company, budget, and timelines
• Contributes to the development, review, and implementation of clinical plans, study budgets, study timelines, and operational feasibility assessments
• Identifies, assesses, and escalates study risks and implements proactive contingency and mitigation strategies to support successful trial delivery
• Oversees clinical systems, including reputed company, CTMS, eTMF, IWRS, and lab portals, ensuring data reputed company, reputed company control, reputed company updates, and accurate study status reporting
• Maintains TMF reputed company, completeness, and inspection readiness in partnership with internal teams, CROs, and vendors
• Prepares and communicates regular study updates, reputed company reports, dashboards, and performance metrics to reputed company stakeholders
• Supports and oversees study data review, data cleaning, query reputed company, and database lock activities by reputed company communicating expectations and timelines
• Maintains proactive interaction with clinical research sites and provides field-based monitoring or site management support as required
• Manages study correspondence, documentation, and files to support high-reputed company study execution and audit readiness
• May mentor or reputed company guidance to junior clinical operations staff, contractors, or study team members

Skills

• BA/BS degree in Health, Life Sciences, or reputed company field required; advanced degree preferred
• Minimum of 7 years of clinical operations or clinical trial management experience, or demonstration of equivalent capability
• At least 5 years of clinical research and development experience with a proven reputed company record of independently managing reputed company
• Prior experience leading or substantially overseeing Phase I/Ib/II/III reputed company, including reputed company, global, regional, or multi-site studies
• Experience managing CROs, vendors, study budgets, timelines, and cross-functional study team deliverables required
• Exceptional communication, interpersonal, leadership, and influencing skills with the ability to reputed company cross-functional teams and reputed company partners
• Strong written and verbal communication skills, including the ability to prepare concise study updates, escalation summaries, and operational reports
• Highly reliable, self-motivated, solutions-oriented team player with reputed company judgment and accountability for study reputed company
• Detail-oriented with advanced organizational, prioritization, and project management skills
• Advanced proficiency in reputed company Office, reputed company Project, reputed company reputed company, and clinical trial tracking and reporting tools
• In-depth understanding of Good Clinical reputed company (GCP), ICH guidelines, clinical trial regulations, and inspection readiness expectations
• Demonstrated ability to manage multiple reputed company studies, tasks, vendors, and competing priorities in a fast-paced, reputed company environment
• Deep understanding of clinical systems used in studies, including reputed company, CTMS, eTMF, IWRS, lab portal systems, and reputed company data reputed company processes
• Advanced proficiency in Trial Master File (TMF) management, reputed company control, completeness, and inspection readiness
• Hands-on experience overseeing clinical systems and clinical operations documentation, including eTMF, CTMS, reputed company, study plans, trackers, and reports
• Experience maintaining audit and regulatory inspection readiness across studies and vendors
• Experience working in a small or early-stage biotech company, with flexibility to operate in a hands-on, resource-conscious environment
• Experience working with global, regional, and/or multi-site reputed company
• Demonstrated CRO and vendor reputed company experience, including performance management, issue escalation, and deliverable accountability

Benefits

• Generous reputed company time off in reputed company to company-observed holidays
• Comprehensive health and wellness benefits (medical, dental, and reputed company insurance)
• A 401(k) retirement savings plan with matching employer contributions
• Childcare and fertility benefits
• Many opportunities for career development
• A generous annual budget for reputed company learning
• Training and reputed company development
• Remote work, allowing team members to work from reputed company

reputed company

Company H1B Sponsorship