Bachelor's Degree Bachelor's degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification.
Req
Requires minimum of 8 years of relevant work experience or equivalent combination of education, training and experience.
Medical or allied medical degree with a minimum of 7 years of work experience or equivalent combination of education, training and experience.
Assoc Mgr, Central Monitoring at IQVIA
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.
Res
Benefits
Vision insurance
Additional Information
Job Overview
Supervise and manage an assigned team of project delivery associates (including senior individual contributor roles) who manage or support studies to ensure quality, time and budget deliverables are met. 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. Line manage Team Leads and mentor junior people managers.
Essential Functions
- Manage staff including leads, and senior individual contributors 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.;
- Lead overall customer delivery for small portfolios at an alliance level and work closely with CMS leads across studies to ensure that CMS deliverables are aligned with the customer KPIs and IQVIA SOPs.;
- Provide support at customer level for Risk Based Monitoring studies during set up phase for small studies.;
- Participate in the selection and on boarding process for new staff by conducting candidate review and participating in the interviewing process for support staff and lead roles.;
- 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. Ability to train staff as and when required.;
- Participate in the allocation of resources to projects by ensuring assignments are appropriate to staff experience and training; organize staff including shift patterns and the number of staff required to meet demand.;
- Assist in ensuring consistent standardized processes are implemented, 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.;
- Works constructively in a matrix framework to achieve project and internal stakeholder deliverables. Actively contribute to initiatives and work in close collaboration with Operations team.;
- Lead and support continuous process improvement initiatives and large departmental initiatives.;
- Mentor associate managers as assigned.;
- Under supervision help with meeting department financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances.; initiating corrective actions.;
- Responsible for on-boarding & off-boarding of staffs.;
- Responsible for Overall Timelines, Quality and Productivity of the Projects, monitor KPIs regularly and meet SLA of the projects.;
- Accountability on the assigned leads and senior individual contributor's study on-boarding, required trainings and transitions.;
- 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.;
- Manage team retention and engagement levels.;
- Manage feedback/escalation to monitor study deliverables/quality and mitigate risk operationally.;
- Present and discuss significant findings and risk mitigation plan at each Quarterly FMT Meeting.;
- Overall manage performance and Perform quality reviews and compliance checks for the central monitors assigned staff on the parameters outlined in Quality Management Plan.;
- Participate in Portfolio level initiatives.;
- Actively participate in client meetings.
IQVIA · Pune, India