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
ICON is hiring talented professionals in Korea as our Korea teams are growing!
Senior Clinical Trial Manager
As Senior Clinical Trial Manager, you will actas the Functional Lead from Clinical Operations with responsibility fordelivery of all Clinical Operations aspects of clinical studies ensuringconsistency with ICON SOPs, study contracts and budgets.
• You would be expected to builda culture of process improvement with a focus on streamlining our processesadding value to our business and meeting client needs.
• Primary point of contact forClinical Operations aspects of designated projects.
• Responsible for developingsuccessful working relationships with clients Responsible for planning, schedulingand implementing.
• Contribute to the developmentand maintenance of cross functional project management plans.
• Responsible for riskmitigation strategies, associated action plan and issue resolution.
• Responsible for leading theClinical Operations project team, including ensuring all necessary projecttraining is provided to assigned staff Provide direction and support to thestudy team
• Collaborate with BusinessDevelopment to ensure timely completion of change orders.
• Track project deliverablesusing appropriate tools.
To be successful, you will have;
• More than 8 years ofprofessional experience in the clinical research filed with at least 2 years ofclinical project management experience;
• Experience in managing siteswith in depth knowledge in local requirements and regulations across APACcountries;
• A bachelor’s degree in ascience or medical area. Ideally you’ll have a master’s degree that focuses onclinical research;
• The ability to communicatewell, an understanding of compliance as well as the confidence to obtainfunding;
• Strong interpersonal skills;
• Good command of written andspoken English;
APAC Study Start Up Compliance Manager
Seoul, Korea, Taiwan or Philippines
As SSU ComplianceManager, you will be responsible for ensuring the Site startup andActivation function adheres to internal and external measures of quality toprevent key audit findings; Oversight over adherenceto processes, and documentation thereof; Ensuringglobal consistency in following the SOPs and Work instructions; Standardizationof processes pertaining to function and measuring success of such; Implementationof corrective action plans and follow-through to successful resolution
•Embrace and contribute to our culture of processimprovement with a focus on streamlining our processes adding value to ourbusiness and meeting client needs and Performance, Identification of risks andgaps in current processes that could lead to potential audit findings, andimplementation of resolutions
• Evaluate process flowand content of functional SOPs for clarity and efficiency
• Interact with otherfunctions to ensure streamlined yet consistent approach to SOPs
• Identify potentialnon-compliance/breaks of quality control steps taken by operations as measuredthrough SOP, WP and industry standards
• Conduct regularspot-checks of key parameters to confirm compliance with internal and externalrequirements, and to ensure that processes function appropriately andconsistently
•Interface betweensystem owners and system end users to maximise compliance; validate updated systemguidelines and ensure roll-out, comprehension and use and application
• Review of functionallearning plans to ensure consistency and automation of assignments
• Workcross-functionally to eliminate gaps in departmental hand-off processes,thereby ensuring information flow across
• Assess and assistregional or project teams with quality control processes for submissionpackages, and review selected studies to ensure quality and timely s departments
• Ensure standardised,global generation and implementation of Documentation of oversight
• Determine algorithms and/orreports for assessment of quality metrics and/or key quality indicators;oversee implementation and tracking of appropriate standard metrics of qualityoversight
• Assess qualitycompliance processes for CDPs, Maintain submissions, and TMF to identify gaps,and assist with corrective measures submissions
• Prepare reports oftrends in Start-up and Activation QC findings for management
• Capitalise on auditfindings to implement preventative actions to prevent further findings
• Demonstrate success inprevention measures by compliance with such, and reduced audit findings
• Assist in thedevelopment of corrective and preventative action plans for the department
• Train new Start-upQuality Compliance staff on processes and procedures
• May participate ininitiatives or committees, including e.g. RACI committee, across Study Start Upand Site Activation or other functions
• Act as key contact forQA from Study Start Up and Site Activation
• Travel (approximately25%) domestic and/or international
To perform this jobsuccessfully, you will have;
• Excellent leadership skills, developed with a collaborative approach todriving performance and success
• Experience in oversight of study deliverables, ideally with provenexperience in the oversight of site identification project/program management and quality management;experience working in a global/multi-regional environment preferred.
Benefitsof Working in ICON
In comparison with our competitor’s andpharmaceutical companies, we provide more flexible and reasonable workingplatforms for coaching and educating new comer’s to be highly respectedprofessionals in our industry. ICON also provides successful candidates with anexcellent employment package and benefits adapted to the current job market. We are more like an extended family with consideration of staff asindividuals allowing a work-life balance.
Additionally, we have cuttingedge technology that will allow you to analyze study specific processes, auditreports, and governance to quality system checks and ensure compliance.
If you would like more information please visit our company website: www.iconplc.com or careers.iconplc.com Or feel free to email me directly: Jennifer.email@example.com
◉ 근무지 : 서울, 2호선 역삼역 3번출구 도보 1분거리
- 근무형태 : 정규직
- 급여 : 면접시협의 (Attractive Compensation & Benefits Package)
- 근무요일/시간 : 월-금, 8시간/일 (Flexible working hours: 10:00~16:00 core time)
- 연차 : 첫해 20일/년, 매년 1일씩 추가 최대 25일
- Sick Leave : 10일/년
- Life Events Leave : 3-7일/년
- 식사/식대 제공 여부 : 점심식대 및 야근시 저녁식대 청구가능
◉ 복리후생 :
- Wellness benefit allowance
- Group life & medical insurances
- Performance Incentive
- 경조사비 지원
◉ 전형절차 : 서류전형 -> HR면접 -> 부서장 면접 / Presentation -> 임원면접
◉ 지원방법 : 이메일지원 firstname.lastname@example.org
◉ 제출서류 : 경력중심 영문이력서
◉ 모집기한 : 채용시까지
◉ 담당자 및 연락처 : Jennifer Kim(김지연), Talent Acquisition Specialist