Assoc Mgr, Central Monitoring

Bengaluru, Karnataka, in
Company: IQVIA
Category: Office and Administrative Support Occupations
Published on 2021-06-22 10:15:40

Job Overview
Supervise and manage the assigned team of project delivery support staff. Work with staff to ensure that all project deliverables are completed ensuring quality deliverables on time and in accordance with Standard Operating Procedures (SOP), policies and practices. Ensure that employees are trained, and individual development is aligned and in place to meet project and organizational needs. Oversee assigned project(s), lead and manage the assigned work streams.

Essential Functions
• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process.
• Conduct on boarding training for new staff in conjunction with Human Resources and Global Talent training programs and mentor staff assigned to them.
• Ensure that staff has the 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 the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training
• rganize staff including shift patterns and the number of staff required to meet demand.
• Assist in ensuring consistent standardized processes are implemented and department deliverables meet or exceed expected productivity, delivery, quality and financial targets
• identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Prepare presentation materials for department meetings.
• Lead and support continuous improvement initiatives.
• Perform quality reviews and compliance checks for the central monitors on the parameters outlined in Quality Oversight Plan.
• Perform spot checks and across LM quality metrics review.
• Conduct Shadow sessions.
• Responsible for Overall Timelines, Quality and Productivity of the Projects.
• Accountability on the central monitors’ study on-boarding and required trainings.
• Manage the effective transitions for Central Monitor.
• Connect with Hyper care and discuss resolutions/recommendations.
• Manage feedback/escalation to monitor study deliverables and mitigate risk operationally.

Qualifications

• Requires minimum of 7 years of relevant work experience or equivalent combination of education, training and experience.
• Medical or allied medical degree with a minimum of 6 years of work experience or equivalent combination of education, training and experience.
• Experience in clinical research field preferred.
• Experience level may vary based on customer specific requirements.
• Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonisation - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Good Clinical system expertise.
• Strong written and verbal communication skills including good command of English language.
• Results and detail-oriented approach to work delivery and output.
• Understanding of clinical/medical data.
• Excellent motivational, influencing and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In depth therapeutic and protocol knowledge.
• Strong organizational and problem-solving skills.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Effective presentation skills.
• Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.
• Ability to lead team and effectively work in team.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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