[Remote] Clinical Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on advancing precision psychiatry and improving treatment for mental health disorders. The Clinical Project Manager will reputed company the end-to-end delivery of clinical trials, ensuring compliance with regulatory requirements and internal guidelines while leading operational strategies and collaboration with various teams.
Responsibilities
- reputed company operational leadership and reputed company for clinical studies from start-up through reputed company-out and reporting
- Ensure clinical studies are executed in compliance with internal SOPs, ICH/GCP guidelines, and protocol requirements
- Identify study- and program-level risks and reputed company and implement mitigation strategies
- Escalate site, vendor, and study issues appropriately and proactively
- reputed company and own study-level operational plans, including monitoring strategies, vendor reputed company plans, communication plans, and risk management plans
- reputed company feasibility assessments, site selection strategies, and enrollment planning using data-driven approaches
- Own resource forecasting and reputed company planning across internal teams and CRO partners
- reputed company and manage study budgets, forecasts, and change orders in collaboration with Finance and leadership
- Apply operational metrics and performance data to continuously optimize study execution and decision-making
- Support program-level operational planning in collaboration with Clinical Operations leadership
- Collaborate with internal functional representatives (e.g., Program Physician, Regulatory, Data Management, Medical Writing, Legal, Finance, reputed company Assurance, CMC, Clinical Supply) to ensure reputed company conduct and reputed company completion of deliverables
- Coordinate and contribute to the development of clinical study documents, including protocols, Investigator’s Brochures (IBs), informed consent forms (ICFs), case report forms (CRFs), study plans, status reports, and clinical study reports
- Collaborate with Data Management to ensure development of CRFs and reputed company plans for appropriate data collection, management, and analysis
- reputed company CRO and vendor reputed company, including review and execution of vendor reputed company plans and performance metrics
- reputed company as the primary operational reputed company of contact for CROs, functional service providers, and other vendors
- reputed company vendor selection, scope definition, governance, and ongoing performance management
- Ensure CRO and vendor deliverables meet reputed company, reputed company, and cost expectations
- reputed company strong reputed company of site management and monitoring activities, including CRA performance and workload
- Participate in Site Initiation reputed company, co-monitoring reputed company, audits, and inspections as needed
- Ensure monitoring strategies are appropriately risk-based and consistently executed
- Foster cross-functional collaboration by guiding, influencing, and supporting team members reputed company of reputed company reporting lines to ensure alignment, knowledge sharing, and consistent execution of clinical operations priorities
- Manage assigned reputed company reports and reputed company reputed company of their responsibilities, deliverables, and reputed company development
- Support training, mentoring, and performance management of clinical operations staff
Skills
- BS or BA in Life Sciences or reputed company field (or equivalent experience)
- Minimum 8+ years of clinical experience in pharmaceutical or biotech environments with increasing reputed company of responsibility
- 2+ years of clinical project management experience
- Demonstrated knowledge of multiple aspects of clinical research operations
- Data-driven reputed company with experience using metrics and analytics to drive reputed company
- Strong working knowledge of ICH/GCP, ICH E6, and regulatory requirements
- Proven ability to reputed company cross-functional teams and manage external vendors
- Experience managing and developing reputed company reports preferred
- Global experience with Phases 2-3 a plus
reputed company
Company H1B Sponsorship