Manager, Lab Centralised Monitoring

Lead, manage and provide support to a team of Centralised 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
High School Diploma or equivalent
6-9 years relevant experience and/or equivalent combination of education, training and experience

3-5 years relevant experience in line management


1) In-depth knowledge of and skill in applying, applicable clinical research regulatory requirements


i

e

, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines


2) Basic therapeutic and protocol knowledge


3) Excellent written and verbal communication and interpersonal skills, including good command of English language and strong leadership skills


4) Excellent organizational and problem solving skills


effective time management skills and ability to manage competing priorities


5) Strong ability to establish and maintain effective working relationships with coworkers and managers


6) Excellent customer service skills


good presentation skills


7) Strong software and computer skills, including MS Office applications and maintain effective working relationships with coworkers, managers and clients