Senior Clinical Trial Manager

We are  seeking a highly motivated, Senior Clinical Trial Manager with extensive medical device clinical trials experience to join our clinical operations team. This is a unique opportunity to join a growing company dedicated to developing a novel medical device  to treat nuero-degenerative diseases.

The Clinical Trial Manager will work in close collaboration with the Clinical Operations & Regulatory Affairs, Product and Engineering leadership teams. The CTM will be responsible for on-site managing clinical trials, partnering with medical monitors and other internal and external parties to ensure clinical trial activities, clinical data and deliverables are of the highest quality . The ideal candidate will have a BA/BS degree or higher, 3-5+ years’ of clinical trial management experience, and be willing to be on-site weekly for the duration of the clinical trial.

Summary of Responsibilities:

• Manage the in-field instrumentation, monitoring, integrity of our investigational device to ensure the highest quality data acquisition, participant safety and comfort. Appropriately train and monitor site staff on the use and maintenance of the investigational device.

• Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable guidelines and other regulatory requirements.

• Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) in order to accurately coordinate clinical study activities.

• Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables.

• Conduct study monitoring visits and co-monitoring visits weekly while study is taking place.

• Provide regular updates of study progression to Clinical Development Lead, Product Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.

• Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.

• Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.

• Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team

• Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including neuroimaging, blood biomarkers, , other laboratory, and device operations manuals).

• Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members.

• Provide oversight and direction to study team members, including vendors, for study deliverables.

Required Qualifications:

• BA/BS degree with at 3 - 5 years’ of medical device clinical trial management experience or advanced degree (MS/PhD) in a bioengineering discipline with at least 2 years’ clinical trial management experience.

• Must have strong knowledge of protocol and investigational device  processes, clinical study design, study planning and management, and monitoring.

• Experience with instrumentation of neurophysiology devices such as polysomnography EEG is strongly preferred.

• Requires proven project management skills and study leadership ability.

• Must have strong knowledge of ICH/GCP guidelines.

• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.