Site Activation Lead
TA Business Partner
About the role
This vacancy has now expired. Please see similar roles below...
"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 any location across APAC.
Role Summary
CON
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.
Roes 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.
Application process
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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.
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