Associate Manager, Onsite Clinical Operations

Parexel International Corporation • King of Prussia, Montgomery County, United States • $200k - $250k / year • 13h ago

Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and "first in human" trials are the first step in testing these novel treatments in humans.

Your time here: As an Associate Manager, Onsite Clinical Operations, you will lead the clinical team as they work on the clinical trials and are involved in all aspects of the trial development process at the Unit. You will work as part of the management team and collaborate with other departments such as Pharmacy, Screening, Laboratory, Clinical, Recruitment, and Project Management. Your work environment is fast-paced, interesting, dynamic, and rewarding.

Develop professionally by gaining experience in delivering high-quality research projects in this growing sector.

What you'll do after training is complete (including but not limited to):

Direct and supervise Clinical Research Associates and work to ensure the efficient clinical operation of the EPCU.
Maintain and further develop the quality management system for clinical operations to include establishing clear expectations for staff performance.
Set Clinical Research Associates schedules to meet business demands of the EPCU and creatively minimize any unnecessary overtime scheduling.
Introduce new technologies and equipment for efficient operations.
Maintain and participate in the fiscal objectives of the unit and recognize cost reduction opportunities.
Oversee and order stock per unit par levels.
Interview and assist with hiring new candidates, as well as new hire orientation.
Collaborate closely with the Medical Director on all clinical operations issues and provide assistance to the EPCU physician staff.
Assist project/study teams in performing study procedures when necessary.
Provide general management assistance and technical support to Project Managers.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all standard work processes to ensure efficient and compliant clinical operation of the Early Phase Clinical Unit (EPCU).
Take appropriate actions to ensure staff and participant safety in the event that hazardous or hostile conditions arise on the unit.
Ensure optimal nightly operations in clinic. Recognize and identify processes to be improved and provide suggestions and solutions.
Display leadership and negotiating skills acting as a conduit between participants and staff and vendors. Act as a resource and mentor for other staff. Train and document training to new staff in their night roles and responsibilities, as applicable. Conduct and accept professional and comprehensive am and pm report.
Present informed consent documents, treatment schemas, and side effects of study related IP and Concomitant medications with trial participants and research team members. Outline study requirements and criteria according to IRB approved Protocol.
Ensure that all study procedures, laboratory and medical tests and other assignments are completed. Maintain an environment conducive to meeting protocol requirements and established timelines.
Assign tasks and clinical procedures to appropriately trained research assistants.

Skills

Demonstrated leadership ability and critical thinking.
Possess knowledge and skills necessary to provide care appropriate to the age and/or indication of the study participants served.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Excellent interpersonal, verbal and written communication skills.
Demonstrated competency in all research-related tasks.

Qualifications:

Bachelor's Degree required or relatable work experience.
2+ years of clinical experience in an acute hospital setting or comparable experience in a clinical research environment is required.
Supervisory experience is required.

Benefits: This role is eligible for an annual bonus, benefits (dental, vision, medical) are available day one of work.

Base Pay Range: $80,000.00 - $100,000.00 annually.

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel's annual performance-based bonus plan, annual salary review and additional total rewards incentives. Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles. For all eligible employees, we offer market leading benefit programs including paid time off, 401k match, life insurance, health insurance, and other benefit offerings in accordance with the terms of applicable plans.

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

#J-18808-Ljbffr