Site Activation Lead

"At ICON, it's our People that set us Apart"

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. ICON Clinical Research is Whole Owned Foreign Company which founded in 1990 in Ireland.We expanded our business from 1995 in APAC region.

Currently we are hiring the Site Activation Lead in Japan

Role Summary

ICON Study Start-up Services are building for a bright future. Site activation is currently one of the most challenging aspects within the project lifecycle. Due to the fast nature of the business Study Start Up works within, we’re looking to develop our team to reach for new frontiers of performance and quality. You will be responsible for the coordination and lead of the country Study Start Up teams for multi-country studies; Driving the teams’ efficiency and adherence to study procedures and timelines; Establishing regulatory requirements and site contracts to ensure a smooth start-up process; Liaising and coordinating with Project Manager to facilitate consistent communication for start up. The Site Activation Lead be the team motivator for the Study Start Up team.

Roles and Responsibilities

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

•Attend BID Defence 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 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, finalisation and review Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs).

•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 co-ordinating the timely negotiation of contracts and budgets with sites.

•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.

•Accountable for the collection of critical documents required for IP Release on assigned studies.

•Where necessary, ensure implementation of an escalation plan as agreed in the study communication plan.

•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.

•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 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.

Experience and Qualification

·   Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company.

·   Minimum of 7 Years of experience in a clinical trial lead environment, preferably with Study Start Up Lead experience

·   Knowledge and experience in the clinical study start up requirements and activities for all assigned countries (or the ability to find this out for new countries)

·   Good organizational skills and the ability to manage multiple tasks

·   Meticulous attention to detail

·   Good written and verbal communication skills. Proficient in English and language required for country assignments

·   Highly developed problem solving skills

·   Strong people management and effective communication skills

·   Strong project management skills

·   Customer service focused

·   Competent computer skills 

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.

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