Site Activation Lead job in

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 specializes 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

Site Activation Lead

Role Responsibility

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

• Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defenses, Kick-Off, Investigator or study team meetings.

• Attend BID Defense meetings, as directed, to provide strategic study start up advice.

• Attend Kick off Meetings, for all assigned studies, to provide strategic input into the study start up discussions

• Draft CA, EC and contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines.

• Work with key parties to draft mitigation plans against contractual targets for key milestones

• Responsible for the inclusion of the Study Start Up Plan in to the Project Management Plan to be shared and agreed with the sponsor

• Fully accountable for the implementation of the Study Start Up Plan for all assigned studies

• Responsible for the Study Start Up element of the Project Communication Plan.

• Responsible for the harmonization of processes and procedures during start up across the region and appropriate training of the team members

• In collaboration with the Project Managers identify and present interdependencies to the project team and track key deliverables against responsible parties, driving forward strategies to prevent “Road Block” situations

• Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including:

• Accountable for the preparation and coordination of submissions to regulatory, ethics and other bodies in all countries for assigned studies

• Accountable for the development, finalization and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs)

• Accountable for the preparation, finalization and review Master and Country Specific EU Clinical Trial Application Forms (xml file) and corresponding data files in collaboration with other relevant departments (EU Only)

• Accountable for providing sponsor advice on the content of drug labels including the review and translations of drug labels where costed for

• Accountable for ensuring all submission packages receive an independent quality review prior to submission

• Accountable for the co-ordination of translations for documents required for submission for assigned studies

• Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system

• Accountable for the timely follow-up for queries made by CA/EC on assigned studies

• Work directly with PM and ICG legal group to establish a defined Clinical Trial Agreement (CTA) process from fallback text to site execution of the CTA. The sponsor may directly be involved in this process or the ICG legal team may discuss directly with the sponsor

• Accountable for the timely tracking and reporting for all assigned studies

• Accountable for leading the country study start up team members involved in the study. May serve as a mentor and coach for these team members as required

• Ensure adherence to the SOW and the site activation budget as per the costing model

• Manage study resources as appropriate per SOW at any phase of the study. Identify out of scope activities and negotiate changes required to SOW and budget as necessary with the PM

• Responsible for the overall quality of the startup phase of the project, address quality issues and ensure implementation of action plans in a timely manner

• Responsible for establishing format of the standard status report with PM to ensure the sponsor and study management needs are achieved, providing the reports as agreed, to the study management team

• Provide regular communication to the project manager identifying issues/targets/resolutions. Innovate, motivate and empower the site activation team to deliver on the timelines milestones with clear measurable objectives. Inform site activation Regional/Country Management teams to mitigate risk as appropriate

• Provide regular updates to Study Start Up Management team including production of study metrics

• Attend all relevant study team meetings throughout the start up phase of all assigned studies

• Ensure effective escalation of issues and feedback including input for Opex (Operational Excellence Meeting) when study is discussed and input into the Global Dashboard for studies in start

• Delegate tasks as appropriate to study start up team while retaining accountability for the successful delivery of the study start up plan

• *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs

• To be fully trained in all systems

• Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation

• Comply with all department requirements regarding information provision and status updating and reporting

• To undertake other reasonably related duties as may be assigned from time to time

Benefits of Working in ICON

We care about our people, since 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. Caring for patients while enjoying what we do and delivering great results is something we can achieve if we know we can count on each other and have a clear vision of where we want to go.

#LI- SZ1

Application process

Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.

Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.

One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.

Reasonable Accomodations

List #1

Day in the life

Shining a Light on Endometriosis Awareness Month

Teaser label

Inside ICON

Content type

Blogs

Publish date

04/18/2024

Summary

Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis

Teaser label

Endometriosis Awareness Month sheds light on this often-misunderstood condition affecting millions worldwide.

The Role of Data Management in Clinical Trials

Teaser label

Industry

Content type

Blogs

Publish date

04/18/2024

Summary

Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials

Teaser label

This blog examines the critical role of data management in clinical trials.

Navigating the Clinical Research Supply Chain

Teaser label

Industry

Content type

Blogs

Publish date

04/12/2024

Summary

Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ

Teaser label

Discover the intricate workings of the clinical research supply chain in this comprehensive guide.

View all

Similar jobs at ICON

Associate Project Manager

Salary

Location

Mexico, Mexico City

Department

Full Service - Development & Commercialisation Solutions

Full Service - Global Business Services

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Technical Project Management

Non-Clinical Project Management

Job Type

Permanent

Description

Associate Project Manager Location: Office Based Hybrid model - Mexico City - Insurgentes Sur.ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to m

Reference

JR118175

Expiry date

01/01/0001

Author

Daniela Guerrero

Author

Daniela Guerrero

Read more Shortlist Save this role

Enterprise Account Manager

Salary

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' cultu

Reference

JR118200

Expiry date

01/01/0001

Author

Jasmine Garcia

Author

Jasmine Garcia

Read more Shortlist Save this role

Go-To-Market (GTM) Business Operations Lead

Salary

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

Reference

JR118201

Expiry date

01/01/0001

Author

Jasmine Garcia

Author

Jasmine Garcia

Read more Shortlist Save this role

IT Support Engineer I

Salary

Location

Mexico, Mexico City

Department

Information technology

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Technical and Desktop Support

Job Type

Permanent

Description

IT Support Engineer Location - Office Flex (3 days at office) - Insurgentes SurAt 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

JR117919

Expiry date

01/01/0001

Author

Daniela Guerrero

Author

Daniela Guerrero

Read more Shortlist Save this role

Clinical Trial Assistant Intern

Salary

Location

US, Lexington, KY

Department

Full Service - Development & Commercialisation Solutions

Location

Lexington

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

JR118177

Expiry date

01/01/0001

Author

Mitzi Overton

Author

Mitzi Overton

Read more Shortlist Save this role

Procurement Analyst

Salary

Location

Mexico, Mexico City

Department

Full Service - Corporate Support

Location

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Procurement

Job Type

Permanent

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech

Reference

JR113915

Expiry date

01/01/0001

Author

Elizabeth Davies

Author

Elizabeth Davies

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?

Site Activation Lead

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

Application process

Who we are

Government and public health services

Why icon? full service mean for you?

Site Activation Lead

Send me a message

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

Application process

Who we are