APAC SSU Compliance Manager

Study Start-Up Compliance Manager, APAC

Location : Korea 

Are you ready to be a part of a successful study delivery team? ICON’s award-winning study execution capabilities have led to the approval of 18 of the world’s top 20 best-selling drugs. Make your experience count for the benefit of patients worldwide. www.iconplc.com

Job functions/responsibilities

As SSU Compliance Manager, you will be responsible for ensuring the Site startup and Activation function adheres to internal and external measures of quality to prevent key audit findings; Oversight over adherence to processes, and documentation thereof; Ensuring global consistency in following the SOPs and Work instructions; Standardization of processes pertaining to function and measuring success of such; Implementation of corrective action plans and follow-through to successful resolution.

•Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs and Performance, Identification of risks and gaps in current processes that could lead to potential audit findings, and implementation of resolutions

•Travel (approximately 25%) domestic and/or international

•Evaluate process flow and content of functional SOPs for clarity and efficiency

•Interact with other functions to ensure streamlined yet consistent approach to SOPs

•Identify potential non-compliance/breaks of quality control steps taken by operations as measured through SOP, WP and industry standards

•Conduct regular spot-checks of key parameters to confirm compliance with internal and external requirements, and to ensure that processes function appropriately and consistently

•Interface between system owners and system end users to maximise compliance; validate updated system guidelines and ensure roll-out, comprehension and use and application

•Review of functional learning plans to ensure consistency and automation of assignments

•Work cross-functionally to eliminate gaps in departmental hand-off processes, thereby ensuring information flow across departments

•Ensure standardised, global generation and implementation of Documentation of oversight

•Determine algorithms and/or reports for assessment of quality metrics and/or key quality indicators; oversee implementation and tracking of appropriate standard metrics of quality oversight

•Assess quality compliance processes for CDPs, Maintain submissions, and TMF to identify gaps, and assist with corrective measures

•Assess and assist regional or project teams with quality control processes for submission packages, and review selected studies to ensure quality and timely submissions

•Prepare reports of trends in Start-up and Activation QC findings for management

•Capitalise on audit findings to implement preventative actions to prevent further findings

•Demonstrate success in prevention measures by compliance with such, and reduced audit findings

•Assist in the development of corrective and preventative action plans for the department

•Train new Start-up Quality Compliance staff on processes and procedures

•May participate in initiatives or committees, including e.g. RACI committee, across Study Start Up and Site Activation or other functions

•Act as key contact for QA from Study Start Up and Site Activation

To perform this job successfully, you will have;

•Excellent leadership skills, developed with a collaborative approach to driving performance and success

•Experience in oversight of study deliverables, ideally with proven experience in the oversight of site identification project/program management; experience working in a global/multi-regional environment preferred.

•Proven experience in a life science or a clinical research environment; industry experience with experience in the function and/or an auditing role

•Cross-functional leadership and influencing skills demonstrating the following key competencies; willing to question the way things are done to improve efficiency

•Ability to make analytical and data focused decisions in a fast paced environment

•Team-focused individual who builds strong relationships and fosters a collaborative work environment across functions

•Strong communicator who adapts style to circumstances and favours an honest and open approach; flexible individual who is excited about the opportunities represented by change

•Ability to successfully manage, positively interact and liaise successfully with all levels of staff at ICON, vendors, and sponsors.

•Due to the nature of this position it may be required to travel, including air travel

•Bachelor’s degree, or local equivalent, in a life-science, scientific discipline and/or medicine, etc.

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

Additionally, we have cutting edge technology that will allow you to analyze study specific processes, audit reports, and governance to quality system checks and ensure compliance. 

If you would like more information please visit our company website: www.iconplc.com  or https://careers.iconplc.com or feel free to email me directly: Jennifer.kim@iconplc.com