Clinical Operations Manager

Location
Remote
Salary
Competitive
Posted
Nov 19, 2020
Ref
Clinical Operations Manager
Required Education
Bachelors Degree
Position Type
Full time

Neuroelectrics Corp. is seeking an experienced Clinical Operations Manager to help oversee a number of clinical trials in the neurological and psychiatric space.  This individual will work closely with the Medical Director and other members of the Clinical, Regulatory and Research teams as well as external CROs to ensure that the trials are conducted in strict adherence to the protocol and all applicable regulations.  Candidates must live in the U.S. but otherwise location is not important; this individual will work primarily from home for the foreseeable future.

Essential Job Functions:

• Supervise external CRO

• Manage (e)Trial Master File and other essential documents

• Process contracts

• Facilitate investigator and study registration updates

• Develop and QC Informed Consent and other study-specific documents

• Develop processes and controlled documents

• Facilitate Clinical Document Change Request activities

• Manage HCP/HCO clinical engagement activities

• Facilitate clinical Risk Assessment and Quality Management System (QMS) activities (e.g. deviations and CAPAs) including activities within the QMS platform

• Manage and/or support clinical audit activities as assigned

• Develop, review, implement and update key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team (e.g. quality, efficiency, consistency)

• Oversee clinical systems updates, enhancements and master data stewardship as required

• Track and report Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations related activities as assigned

Education/ Qualifications:

• Bachelors or equivalent required, preferably in a scientific or health care field

• Minimum five (5) years of direct clinical trial management experience required

• Experience managing clinical trials at investigator sites preferred

• Experience with medical devices preferred

• Experience with epilepsy or another neurological field preferred

• Experience with PC-Windows, word processing, and electronic spreadsheets required

• Knowledge of ICH/GCP, local regulatory authority drug research and development regulations and clinical trial operations required

• Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail

• Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors, and consultants

• Comfortable in a fast-paced environment and able to adjust workload based on changing priorities

• Ability to work effectively within a team matrix as well as independently

• Ability to collaborate and respond to changing circumstances and needs

• Ability to travel may eventually be  required to carry out responsibilities, but not during times of public health risk.

• Ability to work remotely in virtual environment.

• Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)

About the Employer:

Neuroelectrics Corp is a venture-backed life science company currently developing non-invasive technologies to diagnose and treat a wide variety of neurological and psychological conditions.  For more information, please visit our website at www.neuroelectrics.com.

EEO Statement: As an equal opportunity employer, Neuroelectrics Corp. is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Neuroelectrics Corp. employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Neuroelectrics Corp. will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship. Neuroelectrics Corp. shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a), which prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities