Remotery

Clinical Senior Project Manager, Associate Director – Global role, Multisponsor

Posted 4 hours ago

This is a fully remote position, open to applicants in North Carolina.

πŸ“‹ Description

β€’ Oversees interdisciplinary clinical research programs as a Project Manager, ensuring adherence to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), and regulatory requirements.

β€’ Serves as the main point of contact between the Company and the Customer to facilitate the project launch, execution, and closure in line with the contractual agreement.

β€’ Leads the clinical team to ensure adherence to quality standards, timelines, and budget management.

β€’ Responsible for the financial performance of designated projects.

β€’ Accountable for all project deliverables related to assigned projects and/or project regions.

β€’ Coordinates activities and outputs from all project conduct partners while proactively identifying and addressing issues.

β€’ Monitors and assesses project progress by maintaining timelines and utilizing various tracking and analysis tools.

β€’ Oversees project management aspects of inspection readiness across all project conduct, including the Trial Master Files.

β€’ Provides guidance for the development and execution of project plans in alignment with Controlled Documents.

β€’ Independently prepares, organizes, and presents project materials at both internal and external meetings.

β€’ Directs the activities of assigned Project Support personnel; manages and mentors other members of the project management team and clinical staff; fosters team collaboration and communication.

β€’ Generates project management reports for clients and senior management.


⛳️ Requirements

β€’ A Bachelor’s Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related field, or a comparable mix of education and experience.

β€’ Comprehensive understanding of Good Clinical Practice/ICH guidelines, regulatory requirements, the drug development process, and clinical monitoring protocols.

β€’ Experience in a clinical research organization (CRO) and relevant therapeutic areas is preferred.

β€’ Strong aptitude for time management and the capability to work independently.

β€’ Willingness to adopt new technologies.

β€’ Exceptional communication, presentation, and interpersonal skills, both written and verbal.

β€’ Adaptability and the ability to mentor and oversee new staff while managing multiple tasks to meet deadlines and deliver high-quality work in a fast-paced environment.

β€’ Willingness to travel as needed (approximately 25%).


🏝️ Benefits

β€’ Comprehensive health benefits including Medical, Dental, and Vision coverage.

β€’ Company-matched 401k plan.

β€’ Eligibility to participate in the Employee Stock Purchase Plan.

β€’ Opportunity to earn commissions/bonuses based on individual and company performance.

β€’ Flexible paid time off (PTO) and sick leave.

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