Clinical Study Manager

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

📋 Description

• Supervise the implementation and adherence to regulatory standards for clinical trials

• Oversee documentation for studies, negotiations, and the prioritization of team tasks

• Conduct and manage activities related to clinical studies, including site evaluations, monitoring, training, and project closure

• Ensure compliance with ISO, GCP, FDA, and Philips protocols

• Act as a subject matter expert for research sites and investigators

• Offer guidance regarding protocol specifications, study processes, and regulatory requirements

• Assess project documentation for precision and regulatory compliance

• Enhance study efficiency and data integrity through process improvements, data analysis, and validation

• Utilize clinical trial technologies such as EDC, eTMF, and CTMS

• Collaborate with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal departments

• Track study progress in relation to milestones, timelines, and financial plans

• Identify risks, address challenges, and promote continuous improvement

• Provide updates to senior management and ensure audit preparedness

⛳️ Requirements

• A minimum of 5 years of experience in clinical research execution within the medical device sector, pharmaceuticals, biotechnology, academia, or government research is required

• Strong preference for knowledge of clinical trial design and best practices within the medical device field

• Familiarity with pertinent medical device standards, including ISO 13485, ISO 14155, and ICH/GCP guidelines, is preferred

• A bachelor's or master's degree is required

• A doctorate or higher in a relevant field is preferred

• Capability to fulfill minimum physical, cognitive, and environmental job requirements with or without accommodation

• Excellent attention to detail

• A mindset geared towards learning and openness to coaching

• Up to 10% travel may be necessary based on business requirements

• Candidates must reside in the local Pittsburgh, PA area to ensure proximity to study sites

• Authorization to work in the US is required

• Must not require sponsorship for a work-authorized visa now or in the future

🏝️ Benefits

• Potential for an annual incentive bonus

• Sales commission may be available

• Long-term incentives may be offered

• Generous paid time off (PTO)

• 401k plan with up to a 7% match

• Health Savings Account (HSA) with company contributions

• Stock purchase plan

• Education reimbursement program

• Company relocation benefits will not be provided