Senior Clinical Project Manager

Job Description

• As a Clinical Project Manager, you will be accountable for the day-to-day operational activities related to the initiation, management and closure of clinical research projects. You will be responsible for overseeing all aspects of projects, ensuring compliance with regulatory requirements, adherence to timelines, and establishing effective communication among stakeholders and management. • Project Planning: Oversee and provide value-added feedback in the development of comprehensive project plans, including project timelines; provide effective leadership in meeting project milestones. • Study Materials Coordination and Development: Contribute to the development of essential study-related documents (e.g., study protocols, IRB documents, Investigator Brochures) and coordinate procurement and shipping of study products • Budget Management: Manage project budgets and resources effectively, ensuring optimal utilization, cost control and accuracy of invoices. • Risk Management: Identify and mitigate project risks proactively, addressing issues as they arise to minimize impact on project timelines and objectives. Provide open communication with management on risks and opportunities. • Quality Control: Lead and oversee monitoring activities to ensure that the projects are conducted in accordance with established internal and external guidelines and standard protocols; coordinate with QA to assist in qualification procedures, functional audits and support external audits. • Vendor Management: Select and manage third-party vendors, including contract research organizations (CROs) and other service providers, to support project activities. • Data Monitoring: Oversee data collection processes and monitoring at site-level to ensure data quality and integrity throughout the project lifecycle. • Team Management: Lead and coordinate the collaborations of cross-functional project teams on project deliverables. • Communication: Facilitate communication among project team members, investigators, and other stakeholders, providing regular updates on project status and key milestones to management. • Documentation: Maintain accurate and complete project documentation, including study reports for the projects towards regulatory submissions, and other correspondence with regulatory authorities. Familiarity with Veeva eTMF preferred. • Regulatory Compliance: Ensure compliance with internal SOPs, relevant regulatory requirements of health authorities, Good Clinical Practice (GCP) guidelines and other industry regulations.

Qualifications

• Bachelor's degree in a relevant scientific discipline (e.g., life sciences, pharmacy, nursing) required; advanced degree (e.g., Master's, PhD) preferred. • Prior experience in clinical project management or related roles within the healthcare or pharmaceutical industry. • Strong understanding of clinical trial processes, regulatory requirements, and industry standards (e.g. GCP, FDA Tobacco Control Act, applicable parts of 21CFR). • Excellent communication, leadership, and organizational skills. • Ability to work effectively in a fast-paced, dynamic environment, managing multiple priorities simultaneously. • Proficiency in project management tools and software (e.g., Microsoft Project, Excel, PowerPoint). • Certifications (Relevant & Preferred): • Project Management Professional (PMP) certification. • Clinical Research Associate (CRA) certification. • Additional Requirements: • Willingness to travel as needed for project meetings, site visits, and other activities. • Commitment to upholding ethical standards and ensuring participant safety in clinical research.

Benefits

• A place to grow your career. We’ll help you set big goals - and exceed them • People. Work with talented, committed and supportive teammates • Equity and performance bonuses. Every employee is a stakeholder in our success • Cell phone subsidy, commuter benefits and discounts on JUUL products • Excellent medical, dental and vision benefits