Sr Mgr, Clinical Trial Mgmnt, Taipei
About the role
This vacancy has now expired. Please see similar roles below...
"At ICON, it's our People that set us Apart"
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
Sr Mgr. Clinical Trial Management
Job Description;
- *Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
- *As a Professional, the employee is expected to recognize the importance of, and create a culture of, process improvement with a focus on streamlining our processes, adding value to our business, and meeting client needs.
- Actively identify opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned , and promote the sharing of best practices.
- Travel (approximately 25%) domestic and/or international.
- *Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders . May act as the primary point of contact for smaller or single service projects.
- *Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments ; protocol deviation prevention , tracking and reporting; IP management , timely investigator payments .
- *Responsible for driving enrolment as per contracted timelines.
- *Regular oversight of key clinical metrics, including but not limited to : Days on Site (DOS) , Monitoring Visit reports (MVR) and Follow up Letters (FUL) timelines , Action Items (Al) and other quality metrics, to ensure they are met and followed-up as necessary .
- *Oversight of visit report review and approval, including site issue escalation and resolution. This may involve direct review/approval of site visit reports, and interacting with the Central Visit Report Approvers , as appropriate .
- *Ensure clinical data is entered into the ICON CTMS or any other CTMS in a timely and accurate manner.
- *Contribute to the development and maintenance of all clinical elements of cross functional project plans.
- Able to work on multinational studies or take the role of a Global CTM.
- *Responsible for co-ordinating , managing and mentoring the clinical project team to ensure • high performance and productivity (e.g . Days on Site for CRAs) • optimal utilization, • continuous development • minimal turnover A Symbol of Excellence • all necessary project training is provided, documented and filed appropriately . •
- *Active involvement in clinical risk planning and assessment , developing mitigation strategies and associated action plans, issue escalation and resolution. •
- Responsible for the development and maintenance of operational plans for clinical deliverables e.g. CRF completion guideline , Monitoring Plan, Recruitment Plan, Clinical Training Plan, annotated trip report etc. •
- *Ensure the core clinical portions of the Trial Master File (electronic or paper TMF) are up-to-date and maintained in accordance with SOPs and the File Master Plan (FMP), including involvement in archiving as necessary. This includes documented QC checks of in house investigator site files . •
- *Ensure all close-out activities are completed as necessary e.g. End of Trial (EOT) notifications sent, all payments made, CTMS updated, all visit reports finalized and all action items resolved. •
- *Lead and/or actively participate in the conduct of clinical team meetings . •
- *Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverab les. •
- *Implement QC activities , ensure compliance with quality measures , and monitor required quality metrics. •
- Develop a succession plan for clinical study team members and, in the event of a change to the team, ensure an effective hand-over that is appropriately documented . •
- Participate in the hiring interview process, if applicable. •
- *Maintain confidentiality of information , as appropriate . •
- Participate in business development activities including bid defense meetings; may be required to provide input to the clinical strategy . •
- May be required to undertake specific PM tasks, as agreed with Line Manager HR006-SOP-F01Nersion 1 O/ Effective: 10 February 2015 (Ref HR006-SOP) Page 3 of 5 •
- Participate in Company/Departmental initiatives , as requested . •
- Undertake other reasonably related duties as assigned . A Symbol of Excellence
*LI-AL1
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Other
Job Type
Permanent
Description
ICON is looking for a Clinical Pricing Analyst to support Global Development Operations, Global Study and Clinical Management Groups and Therapeutic Area Teams by creation of pricing proposals for cli
Reference
2024-110133
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Regional United States (PRA)
Location
Multiple US Locations
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Patient Recruitment
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR119460
Expiry date
01/01/0001
Author
Mitzi OvertonAuthor
Mitzi OvertonSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Development & Commercialisation Solutions
Location
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
At ICON, it is our people who set us apart. Our diverse teams enable us to be better partners to our customers and help us fulfill our mission to advance and improve patients' lives. Our 'Own It' cult
Reference
JR118201
Expiry date
01/01/0001
Author
Jasmine GarciaAuthor
Jasmine GarciaSalary
Location
US, Bristol, TN
Location
Cary
Raleigh
Winston-Salem
Knoxville
Mt. Pleasant
Hickory
Rocky Mount
Bristol
Piedmont
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Research Site Services
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR119459
Expiry date
01/01/0001
Author
Sasha BrownAuthor
Sasha BrownSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Programming
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-109173
Expiry date
01/01/0001
Author
Jack FisherAuthor
Jack FisherSalary
Location
Mexico, Mexico City
Department
Full Service - Development & Commercialisation Solutions
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own
Reference
JR118445
Expiry date
01/01/0001
Author
Meris MyersAuthor
Meris Myers