Project Manager I, IDEA
About the role
This vacancy has now expired. Please see similar roles below...
This position is primarily responsible for managing all Data Monitoring Committee (DMC)/Data Safety Monitoring Board (DSMB) processes for a clinical trial.
*This is a home-based position.
Job Responsibilities
* Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
* As a 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.
*Travel (approximately 35%) domestic and/or international.
* Manages project in a timely manner in adherence with ICON's SOP's, ICH, GCP and appropriate regulation and liaise with other departments as necessary.
* Delivers projects in accordance with the contract, timelines and study budget
* Identifies out of scope activities and initiates budget change orders and contract amendments
* Attends and presents at Investigator Meetings, Client Kick-Off Meetings, and other client meetings
* Facilitates the electronic endpoint adjudication system for the endpoint adjudication project
* Ensures all necessary study specific training is provided to study team to improve performance and knowledge. Provides coaching I mentoring as necessary.
* Develops and maintains all trial documentation (i.e. Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
* Serves as the primary study contact for client and internal and external study teams.
* Leads internal and external study team meetings.
* Leads internal DMC team.
* Develops and monitors DMC processing workflows to maintain efficiency
* Prepares meeting agenda and facilitates the completion and distribution of meeting minutes
* Facilitates the development of project reports. Generates and distributes project reports to the study team.
* Coordinates DMC committee members and data review process
* Conducts project/system specific training to committee members
* Performs project finance reporting activities
* Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.
* Participates in bid defense and new proposal review activities as necessary
* Participates in internal, client, and regulatory audits
* Other duties as assigned
Requirements
- Bachelors Degree or local equivalent in medicine or science
- Minimum of 1 year of relevant clinical research industry experience
- Basic knowledge of applicable global, regional, local clinical research regulatory requirements; ie Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs), or the ability and willingness to gain this knowledge.
- Highly developed problem solving skills
- Ability to interact effectively and professionally with various levels of staff for both internal and external departments, vendors, or Sponsors
- Excellent computer skills (Microsoft Word, Excel, PowerPoint, Outlook). Experience working with electronic data capture and transfer methods
- Knowledge of medical terminology
- Excellent communication and documentation skills
- Excellent organizational, time management and problem-solving skills
- Strong sense of responsibility and dedication
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
Mexico, Mexico City
Department
Full Service - Commercial Solutions
Location
Mexico City
Sofia
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Proposals
Job Type
Permanent
Description
Business Intelligence AnalystLocation: Hybrid Mexico City - (Insurgentes Sur) At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and h
Reference
JR117427
Expiry date
01/01/0001
Author
Ana LuciaAuthor
Ana LuciaSalary
Location
Mexico City
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Drug Safety
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
2024-110055
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico, Mexico City
Department
Full Service - Medical Affairs & Pharmacovigilance
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program 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 I
Reference
JR116055
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Mexico, Benito Juarez (PRA)
Department
Study Start Up
Location
Mexico City
Benito Juarez
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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
JR118414
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello TaianaSalary
Location
Mexico, Benito Juarez (PRA)
Department
Study Start Up
Location
Mexico City
Benito Juarez
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
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
JR118415
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello TaianaSalary
Location
India
Department
Clinical Operations Roles
Location
India
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
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
2024-108719
Expiry date
01/01/0001
Author
Swathy AnandanAuthor
Swathy Anandan