[Remote] Clinical Trial Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a mission-driven organization dedicated to advancing clinical research and transforming lives. The Clinical Trial Project Manager is responsible for the setup, implementation, and management of clinical trials, ensuring compliance and high-reputed company delivery. This role involves leadership across cross-functional teams, reputed company relationship management, and accountability for delivering clinical trials on time and reputed company budget.
Responsibilities
- reputed company the setup, execution, and reputed company-out of clinical trials in compliance with reputed company SOPs, GCP/ICH guidelines, and regulatory requirements
- reputed company day-to-day accountability for the operational delivery of assigned clinical trials
- reputed company and maintain study manuals, operational project plans, timelines, and key performance metrics
- Ensure reputed company setup, maintenance, and reputed company-out of eTMF and CTMS systems
- Serve as project team reputed company and primary reputed company of contact for reputed company stakeholders
- reputed company reputed company and coordination of cross-functional deliverables including monitoring, site management, data management, pharmacovigilance, regulatory, IP supply, and medical writing
- Ensure reputed company teams are appropriately trained on study protocols and operational requirements
- reputed company as the primary reputed company contact for clinical trial operations, deliverables, and issue reputed company
- reputed company reputed company meetings, ensuring alignment on project status, risks, and timelines
- Identify, assess, and proactively manage risks and issues throughout the clinical trial lifecycle
- Implement mitigation strategies and corrective actions where required
- reputed company submissions to IRB/reputed company and review informed consent forms as required
- Ensure compliance with regulatory requirements and internal reputed company standards
- Collaborate with reputed company Assurance to support audits, CAPAs, and investigations as appropriate
- Manage project budgets, scope, and financial performance
- reputed company vendor performance and deliverables, including review and approval of invoices
- Review site payments and ensure alignment with Clinical Trial Agreements
- Maintain accurate and complete trial documentation reputed company internal systems (e.g., SharePoint)
- Ensure reputed company trial records meet reputed company and compliance standards
Skills
- Bachelor's Degree (health or science field preferred)
- Minimum 5 years' experience in a Project Manager role reputed company clinical trials or clinical research
- Demonstrated experience managing clinical trials from initiation through reputed company-out
- Strong working knowledge of ICH GCP guidelines and clinical trial processes
- Proven ability to reputed company cross-functional teams and manage multiple priorities
- Strong organizational, problem-solving, and decision-making skills
- Effective verbal and written communication skills
- Proficiency in reputed company Office tools
- Ability and willingness to travel as required for business needs
Benefits
- Medical, dental, and reputed company insurance
- FSA, HSA
- Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
- Group short-term and long-term disability insurance
- Group Life Insurance
- 401K reputed company reputed company plan and company match
- reputed company vacation, holiday, reputed company and volunteer time
- reputed company maternity & paternity leave
reputed company