JUMP TO CONTENT
Shortlist
search jobs Search
About the role ICON and you Application Process Day in the life Who we are

Sr Mgr, Clinical Trial Mgmnt - CNS/Rare Diseases

JR065237

About the role

This vacancy has now expired. Please see similar roles below...

ICON is seeking a Sr. Manager, Clinical Trial Management for our CNS/Rare Diseases team! This position can be home-based anywhere in the U.S.
Responsibilities:
  • 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
  • Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance.
  • As a Sr. Manager, 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.
  • 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 enrollment 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.
  • Oversight of visit report review and approval, including site issue escalation and resolution.
  • 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.
  • 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
  • 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).
  • 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.
  • 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.
Requirements:
  • Track record of successful management of the Clinical Operations aspects of regional/global studies/programs
  • A minimum of five (5) years of clinical research experience with at least three (3) years of clinical trial management experience
  • Strong leadership skills, prior successful experience in mentoring CTMs, demonstrated project management ability as well as a positive approach in managing staff, clients and project related issues are necessary to perform successfully in a service-oriented environment.
  • Proven track record in successfully managing change.
  • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
  • Fluent in written and spoken English.
  • Computer literate.
  • Ability and willingness to travel approximately 20% of the time (international and domestic; fly and drive).
  • Extensive use of telephone expected
List #1

Day in the life

Image depicting a career path
Resume Gaps: Showcasing Career Breaks Positively

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Overcoming Resume Gaps In an ideal world, resumes would neatly showcase an uninterrupted career progression. However, In today's dynamic job market, it's not uncommon for professionals to encoun

Teaser label

Periods of unemployment don't have to be a red flag. Learn proven strategies for addressing resume gaps.

Read more
Picture of a resume
One Size Doesn't Fit All: How to Customise Your CV for Every Job

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

The Art of Customisation: How to Tailor Your CV for Any Role or Industry In today's competitive job market, a one-size-fits-all CV often misses the mark. To truly stand out and position yourself a

Teaser label

Discover strategies to highlight your expertise, role-specific skills, and industry knowledge to help your CV stand out.

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
View all

Who we are

Press play to find out more

Similar jobs at ICON

Site Activation Lead

Salary

Location

Mexico, Mexico City

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Site Activation

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

JR118866

Expiry date

01/01/0001

Olivia Molina

Author

Olivia Molina
Olivia Molina

Author

Olivia Molina
Read more Shortlist Save this role
Read more Shortlist Save this role
Senior Pharmacovigilance Associate

Salary

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

JR119922

Expiry date

01/01/0001

Florencia Pistolesi

Author

Florencia Pistolesi
Florencia Pistolesi

Author

Florencia Pistolesi
Read more Shortlist Save this role
Read more Shortlist Save this role
Intern

Salary

Location

US, New York, NY, Whitesboro

Department

Full Service - Development & Commercialisation Solutions

Location

Whitesboro

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Intern

Job Type

Intern

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

JR115822

Expiry date

01/01/0001

Hanna Pitcairn

Author

Hanna Pitcairn
Hanna Pitcairn

Author

Hanna Pitcairn
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate 2

Salary

Location

Argentina

Department

Clinical Monitoring

Location

Argentina

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

A CRA is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You will be joining a progra

Reference

2024-110427

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Read more Shortlist Save this role
Clinical Research Associate - All levels

Salary

Location

Argentina

Department

Clinical Monitoring

Location

Argentina

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. You will be joining a program tak

Reference

2024-110340

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Read more Shortlist Save this role
Medical Data Reviewer

Salary

Location

Brazil, Argentina

Department

Clinical Operations Roles

Location

Argentina

Brazil

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Trial Support

Job Type

Permanent

Description

As a Medical Data Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2023-107335

Expiry date

01/01/0001

Tulio Sanquiz

Author

Tulio Sanquiz
Tulio Sanquiz

Author

Tulio Sanquiz
Read more Shortlist Save this role
Read more Shortlist Save this role

Browse popular job categories below or search all jobs above