Project Manager II, IDEA job in

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

Senior Project Manager, IDEA

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. This position is primarily responsible for managing all Data Monitoring Committee (DMC) and/or endpoint adjudication processes for multiple clinical trials.

Overview of the Role

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 projects 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 endpoint adjudication projects
Ensures all necessary study specific training is provided to study teams to improve performance and knowledge.
Provides coaching / mentoring as necessary.
Develops and maintains all trial documentation (ie Charter, Procedure Manual, Site Manual, Adjudication Forms, Communication Plan, System Requirement Specifications, Data Transfer Specifications, and Committee Training Manual)
Performs user acceptance testing of electronic endpoint adjudication system
Performs data reconciliation
Serves as the primary study contact for client and internal and external study teams.
Leads internal and external study team meetings.
Leads internal DMC and endpoint adjudication processing teams.
Develops and monitors DMC and endpoint adjudication 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 and Endpoint Adjudication Committee members and data review/adjudication processes
Conducts project/system specific training to committee members
Implements Quality Control measures for adjudication process and adjudication outcomes as necessary
Performs project finance reporting activities
Provides feedback to senior management on project status, metrics, client satisfaction and staffing issues.*
Participates in interview process for new staff.
Develops and implements staff training/orientation plans.
Participates in bid defense and new proposal review activities as necessary
Participates in internal, client, and regulatory audits
Participates in the development and implementation of departmental initiatives.
Other duties as assigned

Role Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• US/LATAM/CAN: 2 years Clinical Trail Project Manager experience
• EU/APAC: Prior relevant Clinical Trail Project Manager 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.
• Prior clinical trial experience
• 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
• Attentiveness to detail and accuracy; ability to maintain quality standards
• Ability to follow instructions/guidelines, utilize initiative and work independently
• Proven ability to multi-task, manage competing priorities and timelines
• Ability to manage team members and processes
• Willingness and aptitude to learn new skills
• Due to the nature of this position it may be required for the employee to travel. Therefore, dependent on the employees’ location, the employee may be required to possess a valid Drivers license.
SECTION 4: EDUCATION REQUIREMENTS
(List requirements in bullet format.)
• Bachelors Degree or local equivalent in medicine or science
• Licensed nursing professional or similar medical/scientific certification

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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

List #1

Day in the life

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.

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.

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.

View all

Similar jobs at ICON

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

Author

Tulio Sanquiz

Author

Tulio Sanquiz

Read more Shortlist Save this role

Senior CRA

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. A CRA is a professional who cont

Reference

2023-103904

Expiry date

01/01/0001

Author

Tulio Sanquiz

Author

Tulio Sanquiz

Read more Shortlist Save this role

Principal Biostatistician

Salary

Location

Ireland, United Kingdom, South Africa, Poland, Bulgaria, Spain, Romania, Czech Republic, Slovakia

Department

Biometrics Roles

Location

Bulgaria

Czech Republic

Ireland

Poland

Romania

South Africa

Spain

Slovakia

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Statistics

Job Type

Permanent

Description

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

Reference

2023-104906

Expiry date

01/01/0001

Read more Shortlist Save this role

Principal Medical Writer

Salary

Location

Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland

Department

Medical Affiars & Medical Writing Roles

Location

Belgium

Denmark

France

Germany

Netherlands

Spain

Switzerland

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Medical Writing

Job Type

Permanent

Description

As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be

Reference

2023-103952

Expiry date

01/01/0001

Author

Natalia Roth

Author

Natalia Roth

Read more Shortlist Save this role

Project Manager, PCS

Salary

Location

Colombia, Bogota

Department

Full Service - Development & Commercialisation Solutions

Location

Bogota

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Project/ Program Management

Job Type

Permanent

Description

The role: Candidate will work with the in-house client managers and freelance linguists/suppliers to fulfill translation project scopes. They contract with linguists from all over the world, monitor

Reference

JR119284

Expiry date

01/01/0001

Author

Olivia Molina

Author

Olivia Molina

Read more Shortlist Save this role

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

Author

Olivia Molina

Author

Olivia Molina

Read more Shortlist Save this role

Full Service

ICON Strategic Solutions

Government and public health services

Global Business Services

Overview of Service Lines

Why icon? full service mean for you?

graduate What does full service mean for you?

Project Manager II, IDEA

About the role

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

ICON and you

ICON history

Career Pathways

Benefits & Rewards

DE&I

Environmental, Social & Governance

Women in IT

A better career. A better world. A better you.

Who we are