Clinical Trial Manager - Vaccines
About the role
This vacancy has now expired. Please see similar roles below...
Job Profile Summary
- To act as the Functional Lead from Clinical Research Services with responsibility for delivery of all clinical aspects of clinical studies.
- To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates (CRAs) assigned to a given clinical study
- For the delivery of all aspects of monitoring and site management
- Ensuring consistency with ICH/GCP and applicable ICON Standard Operating Procedures (SOPs), applicable regulations, the Monitoring Plan and ensuring the clinical portion of the study is inspection ready at all times.
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.
- Participate in 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.
- 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 Report (MVR) and Follow up Letters (FUL) timelines, Action Items (AI) 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 and may take the role of a Global CTM if appropriate.
- Responsible for coordinating and managing the clinical project team to ensure:
- high performance and productivity (e.g. DOS for CRAs)
- optimal utilization
- minimal turnover
- all necessary project training is provided, documented and filed appropriately.
- Responsible for documenting clinical risks and developing mitigation strategies and associated action plans, including 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 deliverables.
- Implement QC activities, ensure compliance with quality measures and monitor required quality metrics.
- Maintain confidentiality of information, as appropriate.
- Participate in business development activities such as bid defense meetings
- May be required to undertake individual, finite PM tasks under supervision and with support of the Line Manager.
- Participate in Company/Departmental initiatives, as requested.
- Undertake other reasonably related duties as assigned.
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
Ireland, Dublin
Department
Full Service - Corporate Support
Location
Dublin
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Legal
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 I
Reference
JR117509
Expiry date
01/01/0001
Author
Maya KatsarskaAuthor
Maya KatsarskaSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug Safety
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR116196
Expiry date
01/01/0001
Author
Florencia PistolesiAuthor
Florencia PistolesiSalary
Location
Barcelona
Department
Project Management Roles
Location
Barcelona
Business Area
ICON Strategic Solutions
Job Categories
Project Management
Job Type
Permanent
Description
Responsible for outsourcing and facilitation of the delivery of (currently only preclinical) CPSS aspects of drug projects. Monitors that these activities fall within agreed time, budget and quality.
Reference
2024-110073
Expiry date
01/01/0001
Salary
Location
Chile
Department
Clinical Monitoring
Location
Chile
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
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
2024-107984
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda ObregonSalary
Location
US, Blue Bell (ICON)
Department
Full Service - Corporate Support
Location
Blue Bell
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Human Resources
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 I
Reference
JR117974
Expiry date
01/01/0001
Author
Frank LampartAuthor
Frank LampartSalary
Location
Ireland, Dublin
Department
Full Service - Development & Commercialisation Solutions
Location
Farmingdale
Dublin
Reading
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
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 I
Reference
JR116607
Expiry date
01/01/0001
Author
Caroline LockAuthor
Caroline Lock