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

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

Home Sweet Office: Why Culture Compatibility Matters

Teaser label

Inclusion & Belonging

Content type

Blogs

Publish 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

Explore how aligning with the right company culture can transform your work environment into a home away from home.

Precision Medicine: How Personalised Therapies are Transforming Healthcare

Teaser label

Industry

Content type

Blogs

Publish 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

Discover how precision medicine is revolutionising healthcare by tailoring treatments to each patient.

Day in the life of a Clinical Data Mangement Project Manager

Teaser label

Our People

Content type

Blogs

Publish 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

Teaser label

Deepak shares his experience as Clinical Data Management Project Manager at ICON Strategic Solutions.

View all

Similar jobs at ICON

Data Management Trial Manager - Remote Based in US

Salary

Location

United States

Department

Biometrics Roles

Location

United States

Remote Working

Remote

Business Area

ICON Strategic Solutions

Job Categories

Clinical Data Management

Clinical Data Scientist Lead

Clinical Systems

Data Standards Consultant

Job Type

Permanent

Description

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

Reference

2024-110193

Expiry date

01/01/0001

Author

Jeffrey Villasenor

Author

Jeffrey Villasenor

Read more Shortlist Save this role

Sr. 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

JR118865

Expiry date

01/01/0001

Author

Olivia Molina

Author

Olivia Molina

Read more Shortlist Save this role

Diversity in Clinical Trials Intern

Salary

Location

US, Raleigh, NC

Department

Full Service - Corporate Support

Location

Raleigh

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Intern

Job Type

Intern

Description

Reference

JR118340

Expiry date

01/01/0001

Author

Mitzi Overton

Author

Mitzi Overton

Read more Shortlist Save this role

Principal Biostatistician

Salary

Location

Regional United States (PRA)

Location

Montreal

Boston

Farmingdale

Multiple US Locations

Whitesboro

Burlington

Blue Bell

Rochester

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Biostatistician

Job Type

Permanent

Description

Reference

JR117634

Expiry date

01/01/0001

Author

Tallulah Pierre

Author

Tallulah Pierre

Read more Shortlist Save this role

Single-Sponsor, CRA II or Senior CRA

Salary

Location

US, Blue Bell (ICON)

Location

Raleigh

Blue Bell

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Monitoring

Job Type

Permanent

Description

Requirements:Must be located within the U.S.Must have 12+ months of independent monitoring experience as a CRAAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better

Reference

JR119530

Expiry date

01/01/0001

Author

Sarah Wood

Author

Sarah Wood

Read more Shortlist Save this role

Principal Clinical Data Scientist Lead

Salary

Location

Mexico, Mexico City

Location

Bogota

Mexico City

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Clinical Data Scientist Lead

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

JR118993

Expiry date

01/01/0001

Author

Tallulah Pierre

Author

Tallulah Pierre

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

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

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

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

Who we are