Position Overview The Project Manager is responsible for the overall cross-functional leadership and successful delivery of assigned clinical research projects, ensuring projects are completed within defined timelines, budgets, quality standards, and applicable regulatory requirements. The Project Manager serves as a primary point of contact for clients and leads internal cross-functional teams, external vendors, and other stakeholders. This role independently manages complex clinical trials, proactively identifies and mitigates risks, and provides strategic guidance to clients and project teams. Key Responsibilities Independently lead assigned clinical research projects, ensuring delivery within agreed timelines, budgets, scope, quality, and regulatory requirements. Serve as primary client contact and maintain proactive relationships with sponsors, internal teams, and external vendors. Lead cross-functional project teams and third-party vendors to support effective collaboration and timely project execution. Develop and maintain project plans, timelines, budgets, resource forecasts, and project documentation. Identify, assess, and proactively manage project risks, issues, and changes, implementing appropriate mitigation and corrective actions. Lead project meetings, communicate status and key issues to clients and senior management, and track action items to completion. Maintain a complete, accurate, and inspection-ready Trial Master File (TMF) throughout the project lifecycle. Support Business Development activities, including budgets, contracts, and change orders. Qualifications & Experience Bachelor's degree or higher, preferably in a scientific or related discipline; equivalent experience may be considered. 7+ years of clinical research project management experience in clinical research, medical device, or CRO environments, including 3+ years managing multi-center clinical studies. Oncology clinical trial experience, particularly non-small cell lung cancer (NSCLC), strongly preferred. Experience independently managing multiple clinical research projects simultaneously. Experience managing U.S. and global, single- and multi-center clinical trials. Phase 3 clinical study experience preferred. CRO experience strongly preferred. Knowledge & Skills Strong knowledge of ICH-GCP, clinical research regulations, ethics requirements, and 21 CFR Part 11. Excellent organizational, communication, leadership, and problem-solving skills. Demonstrated ability to lead cross-functional teams and build effective relationships with clients, colleagues, vendors, and senior leadership. Strong understanding of clinical trial processes and cross-functional interactions throughout the clinical development lifecycle. Ability to manage project risks, competing priorities, and changing client needs. Proficiency in Microsoft Office, including Word, Excel, and PowerPoint; SharePoint and electronic TMF experience preferred. Strong attention to detail and ability to manage multiple priorities in a fast-paced environment. Ability to work independently and exercise sound judgment with minimal supervision.

Pay:

From $105,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance Application Question(s): How many years of Oncology related experience do you have?

Education:

Bachelor's (Required) Ability to

Commute:

Newtown, PA 18940 (Required)

Work Location:

Hybrid remote in Newtown, PA 18940