Assoc Mgr, Lab Cent 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

• This position requires a combination of Technical Skills like managing and assigning centralized monitoring activities and responsibilities (moderate to complex protocols/ non-protocol tasks) competently with 1+ years of direct line manager experience

• The candidate needs to be based out of Kochi and should operate from office all 5 days of the week.

• Need a strong dynamic lead from Clinical background for this position, given that he/she will be assigned the responsibility to lead this site.

• Education: Life-science background

• Exp: 5+ years of relevant work experience

• Should have experience in People Managing role in Hospital or Lab background  

• 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 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
  • 5-8 Years.
  • 5  relevant experience and/or equivalent combination of education, training and experience. 1-2 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.

  Job Overview
  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 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
  • 5-8 Years.
  • 5+  relevant experience and/or equivalent combination of education, training and experience. 1-2 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.