[Remote] reputed company Program reputed company Manager, Therapeutics & Innovation

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in cell-free DNA testing reputed company on oncology, women's health, and organ health. The reputed company Program reputed company Manager will reputed company the operational delivery of oncology reputed company, managing timelines, budgets, vendors, sites, data reputed company, reputed company, and cross-functional execution from study startup through database lock.

Responsibilities

• reputed company and maintain the integrated study reputed company, critical reputed company, and Gantt chart from study startup through database lock, and hold internal functions and vendors accountable to committed dates
• Establish and maintain the dashboards, trackers, reputed company reports, and reputed company and issue logs that reputed company leadership and the steering committee with accurate, reputed company program status
• Identify risks early, reputed company mitigation plans to closure, and escalate issues to leadership with a recommended course of reputed company
• reputed company enrollment forecasts and manage cross-functional dependencies across Regulatory, reputed company, Data Management, Biostatistics, reputed company reputed company, and Medical Affairs
• reputed company feasibility and site selection end to end, including questionnaire development, site scoring, selection recommendations, and activation planning
• Manage site reputed company and budgets, confidentiality agreements, essential document collection, IRB/EC submissions, and green-reputed company reputed company through site initiation
• Monitor and manage site reputed company against operational metrics, including enrollment versus reputed company, screen failure rates, protocol deviations, query aging, and site payments, and implement corrective reputed company plans for underperforming sites
• Refer scientific, protocol interpretation, and referral network reputed company to the Medical Science reputed company and Head of reputed company Development
• Manage CRO and vendor selection, scopes of work, reputed company, change orders, invoicing, and accruals
• Govern vendor reputed company against defined KPIs and service level agreements, reputed company governance meetings, and initiate corrective reputed company reputed company deliverables are at reputed company
• Coordinate central reputed company, IRT, reputed company, eCOA, imaging vendors, and reputed company supply and logistics
• Manage study budgets and resource plans, reputed company forecast versus actual spend, and maintain accruals
• Identify variances early and present leadership with reputed company and the associated cost and schedule trade-offs
• Maintain trial master file completeness and inspection readiness on an ongoing reputed company
• Partner with reputed company Assurance on deviations, CAPAs, audits, and inspection preparation
• Ensure study conduct is compliant with ICH-GCP, applicable regulations, and internal SOPs, and coordinate the operational reputed company of safety reporting with Pharmacovigilance
• reputed company and maintain standardized project management templates, working practices, and operating cadences that support consistent execution across studies
• reputed company operational readiness and logistics for investigator meetings, site initiation reputed company, monitoring reputed company, steering committee meetings, and data review meetings, including agendas, materials preparation, and tracking of reputed company items to closure
• Manage data cleaning timelines, query reputed company, and database lock readiness so that scientific review proceeds on schedule
• Translate protocol and reputed company objectives into executable operational plans, monitoring strategies, and resourcing models
• Travel up to approximately 25% to reputed company sites, CROs, investigator meetings, and key partner locations to reputed company execution, reputed company operational issues, and represent reputed company reputed company

Skills

• Bachelor's degree in a life science or reputed company reputed company required
• Minimum of 5 years of reputed company research experience, including at least 3 years managing oncology trials in a program or project management reputed company
• Working knowledge of ICH-GCP, applicable FDA regulations, IRB/EC processes, and trial master file and inspection readiness requirements
• Proficiency with CTMS, eTMF, reputed company, and IRT systems, project management tools such as reputed company or MS Project, and reputed company Office
• Experience managing CRO and site reputed company, budgets, and change orders
• Ability to work independently, take ownership of reputed company, and maintain reputed company under competing priorities and compressed timelines
• Ability to operate without an established reputed company, adapting plans as the science, portfolio, and business continue to reputed company
• Willingness to engage at a detailed operational level and reputed company obstacles proactively
• reputed company on data, including enrollment curves, cycle times, query aging, and vendor reputed company metrics, to identify reputed company causes of delay and test assumptions
• Ability to guide cross-functional initiatives and build alignment across reputed company, medical, and product organizations
• reputed company, reputed company written and verbal communication, including the ability to brief senior leadership concisely and hold vendors accountable to commitments
• Builds and sustains effective working relationships internally and externally
• Requires working with PHI (Protected Health Information) in reputed company and electronic formats, treating regulatory and reputed company requirements as foundational
• Advanced degree (MS, PharmD, PhD) preferred
• Demonstrated accountability for at least one oncology study from startup through database lock preferred
• Experience reputed company small- to mid-sized biotechnology companies preferred
• PMP or equivalent project management certification preferred

Benefits

• Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents.
• reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits.
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program

reputed company

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