Manager, Lab Monitoring

Position: Manager, Lab Central Monitoring
Role:
Manager, Lab Central Monitoring

Location:

Thane/Bangalore
Work mode:
Office based

Experience:

10+ years | 3–5 years people/line management

Job Overview

Lead, manage and provide support to a team of Centralized Monitoring project coordinators (CPCs) in the management of the assigned activities. Manage staff according to the organization’s policies and applicable regulations

Essential Functions
Lead, manage and provide support to a team of Centralized Monitoring project coordinators (CPCs) in the management of the assigned activities. Manage staff according to the organization’s policies and applicable regulations
Planning, assigning, and directing work, mentoring and assist in training of CPCs. Appraising performance and guiding professional development rewarding and disciplining employees addressing employee relations issues and resolving problems. Approve actions on human resources matters.
Establish a close working relationship with the global project team, operational teams and appropriate counterparts to ensure consistent quality, global delivery, productivity of all studies which may include sponsor specific standards and procedures.
Participate in the selection and on boarding process for new staff, conduct candidate review and interviews. Conduct on boarding training for new staff in conjunction with Human Resources and Global Talent training programs.
Ensure that the staff has proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
Participate in assigning staff to studies that are appropriate to their experience and training, track assignment of the staff to projects and report relevant metrics to management
Track staff output quality by conducting regular mini audits.
Participate and lead in investigation on quality incidents including root cause analysis, and identification of a robust CAPA (corrective & preventive action) plan.
Identify risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
Regularly track metrics as agreed with management for individual staff and the department
Participate in continuous improvement programs at a departmental level to ensure excellent service delivery and quality focus.

Qualifications
6-9 years’ relevant experience with 3-5 years relevant experience in line management.
In-depth knowledge of and skill in applying, applicable clinical research regulatory requirements.
Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Basic therapeutic and protocol knowledge.
Excellent written and verbal communication and interpersonal skills, including good command of English language and strong leadership skills.
Excellent organizational and problem solving skills. effective time management skills and ability to manage competing priorities.
Strong ability to establish and maintain effective working relationships with coworkers and managers.
Excellent customer service skills, good presentation skills.
Strong software and computer skills, including MS Office applications and maintain effective working relationships with coworkers, managers and clients.