Parexel Early Phase Clinical Unitsupports 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 a Clinical Operations Manager, 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 professionallyby 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):

• Manage and oversee clinical staff day to day activities providing direct supervision, including but not limited to the following: hiring, training (ensuring tools and support is provided to enable staff to be competent and successful in roles), scheduling, and maintain time sheets.
• Meet regularly with staff and maintains1:1 meetings, coaching/counseling. Escalates appropriately concerns and issues to senior leadership and HR as appropriate.
• Identify, develop and modify operational systems, training programs, tools, processes and/or materials to optimize staff develop, high performance culture, and streamline operations in the clinic,
• Meets regularly with Operations Management team (and others as applicable) to proactively plan needs for upcoming studies, including identification of strategies to optimize staffing
• Possesses thorough knowledge of all current study protocols.
• Provide clinical input on protocols in development and assess feasibility. Identifies risks and strategies to mitigate risk and supports leading next steps with implementation.
• Provides Department feasibility assessments for study protocols and design when programs are being considered through Business Development.
• Interface with key departments to discuss status of current studies at PAREXEL, as well as strategies for any potential challenges, including but not limit to staffing, vendor or hospital issues.
• Provide continued contact with the Sponsor for duration of the clinical study including entertaining Sponsor during site visits.
• Work closely with Advertising/Enrollment Departments on recruitment strategy/issues as appropriate.
• Review Draft consents and offers suggestions to Regulatory Compliance.
• Manage all aspects of departmental performance improvement strategies including: identifying areas for improvement, developing action plans in conjunction with all affected areas/staff, tracking results and reporting results to upper management.
• Determine the necessity for the creation of departmental Clinical Operating Guidelines (COGs) and Standard Operating Procedures (SOPs) to meet hospital/facility requirements.
• Maintain and update knowledge of Good Clinical Practices (GCPs)/Good Documentation Practices (GDPs) and their proper application. Reinforces the use of GCPs/GDPs departmentally through example and staff training.

Skills

• Demonstrated leadership ability and critical thinking.
• Have the 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

• Education: Bachelors degree required
• 3 years of clinical experience in an acute hospital setting or comparable experience in a clinical research environment is required.
• Located within a commutable distance to Glendale, CA
• 3 years managing staff.