Manager, Clinical Operations

CareAbout•Overland Park, KS

1d•Remote

About The Position

The Manager, Clinical Operations is responsible for the management and coordination of Clinical Operations team members and clinical activities during clinical trial execution. The Manager, Clinical Operations will ensure clinical activities are completed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s.

Requirements

High School diploma or GED, related job experience and demonstrated leadership involvement required
Excellent written and verbal communication, leadership, interpersonal and organizational skills.
Customer service focused, able to work in a fast-paced environment.

Nice To Haves

college degree and experience in Phase 1 clinical research preferred
People leadership/management, preferably 1+ year
Phlebotomy experience preferred
RN/BSN/Paramedic Preferred

Responsibilities

Management of the Clinical Operations team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
Oversee, manage and/or coordinate the training and training records for the Clinical Operations team.
Proactively assess learning opportunities for the Clinical Operations team.
Provide direction to team members during the execution of clinical trial activities.
Ensure Clinical Operations study and staffing needs meet protocol requirements and are scheduled within study timelines.
Assure supplementary clinical training is performed to meet protocol requirements, including collaboration with pharmacists and PIs on the creation of dose training material and subsequent training of clinical safety officers and technicians.
Ensure the confidentiality of clinical trial participants and sponsors is respected.
Maintain and advocate a high level of customer service and quality within the department.
Perform clinical trial activities, including but not limited to, data collection, safety measurements, sample handling and in-house testing.
Performs protocol reviews.
Provide a continuous line of communication with management teams on the progression of clinical trials.
Assist in sponsor visits and regulatory audits and ensure the timely resolution to any related findings.
Ensure the resolution of data queries in a timely manner and escalate when necessary.
May review and/or approve in-life audit findings, tracks finding trends and makes appropriate corrective actions measures, when deemed necessary.
Participate in SOP and protocol reviews and assist in ensuring clinical processes are streamlined.
Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
Hold meetings with clinical members to communicate clinical trial needs and/or departmental objectives.