Clinical Trials Manager Jobs

SPARK Neuro is an applied-neuroscience company building medical technology. We’re a team of

passionate people, working together to develop high-impact neurodiagnostic technologies. Our products

advance patients’ and doctors’ ability to measure and optimize brain health.

Mission

SPARK Neuro’s AI technology will revolutionize brain measurement for better care, therapeutic discovery,

and human optimization.

Vision

A world where measuring and caring for brain health is universally accessible. The Clinical Trial Manager is responsible for overseeing and managing insourced or outsourced studies including all operational aspects of SPARK Neuro’s medical device clinical trial(s), while ensuring patient safety, data quality and integrity. The ideal candidate will have a strong sense of ownership, a attention to detail, and a high degree of urgency to meet study objectives. Success in this role is supported by personal leadership as an individual contributor and collaborative team member, excellence in proactive written and verbal communications, and a willingness to wear multiple hats. This role calls for a hands-on person to manage all aspects of SPARK’s clinical studies at a dynamic young company with ambitious goals that aim to make a significant impact on our aging population

.

This is a remote position with occasional travel.

Responsibilities

● Responsible for operational execution of assigned Medical Device studies. Manages trial deliverables as well as vendor relationships and performance to ensure that clinical studies are completed in accordance with management’s expectations of time, cost and quality

● Develops outsourcing specifications for vendor requests for proposal, leads vendor selection

● Oversees study activities including study start-up, close out, and completion of Trial Master File.

● Ensures oversight of clinical trials including the selection of investigational sites, adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study/ site personnel. Monitor all vendor performance, communicate vendor expectations, and track vendor performance metrics

● Responsible for overseeing negotiation of site CTAs in conjunction with the Director of Clinical

Operations and the Legal Department.

● Delegates and manages tasks and responsibilities to other team members assigned to the study

● Oversees operational study level feasibility, recruitment strategies and the delivery of the approved

study protocol(s)

● Provides review and input of selected study clinical documents (protocol, operational plans,

monitoring plans, monitoring visit reports, etc) based on SOP, ICH/GCP guidelines and with site and

patient centric view

● Responsible for overall risk management of study to assure timely delivery to quality, budget and timelines. Escalates issues to stakeholders as appropriate and ensures successful implementation

● Plans and conducts study related meetings including investigator meetings and ad boards.

● In collaboration with data management, facilitates ongoing data review in preparation for interim,

final analyses and review of CSR

● Responsible for providing program director regular status updates

● Establish and maintain effective communication and collaboration with functional area peers in order to meet program objectives, proactively identify study risks and support achievement of goals

● Participates in SOP development as reviewer of local or global documents. Supports development and improvement of departmental and company procedures and shares best industry practice

● Mentor project team members regarding project specific activities, reporting and tools

● Other duties as assigned

Requirements

● BA/BS in life sciences or equivalent

● At least 6 years of clinical research experience including at least three (3) years having effectively

led a study/studies project from inception to completion coupled with demonstrated ability to hold

team members accountable

● Experience with medical devices (hardware and/or software) ideally obtained in a Medical

Device/biotech/pharma setting

● Working knowledge of Good Clinical Practices (GCP)s

● Awareness of FDA regulations and guidelines with respect to clinical trials, and applicable

international regulatory requirements

● Knowledge of clinical operations, project management tools and processes.

● Ability to effectively manage interactions with investigators ensuring cooperation for achieving

program goals

● Knowledge of device and or pharmaceutical development and regulatory processes

● Ability to resolve problems and lead projects of diverse scope, analyze data and exercise sound

judgment along with the ability to recommend business alternatives to senior management

● Proficient MS Office/Google docs skills including data review analysis tools

● Ability to travel up to 30%

● Ability to work from home independently