Clinical Trial Specialist/Senior Clinical Trial Specialist

We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.

Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and EuropeFull range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trialWe combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.

Why work with us?We are a global team making a difference in the world – our clinical trials improve the health of millions worldwideCompetitive salary and benefitsFlexible and agile working arrangements - onsite, hybrid or WFH (dependent on location)Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn fromA focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events

About the role:The CTS/Senior Clinical Trial Specialist (CTS) is a member of the clinical project team responsible for supporting clinical trial activities as the in-house site start-up and maintenance specialist. As part of the clinical trial project team, the CTS is responsible for ensuring clinical trials are conducted according to Regulations, ICH guidelines, project plans, IRB requirements, and applicable SOPs and guidelines. They support the project manager, clinical trial manager and clinical operations management related to the project startup, maintenance, and close-out activities in specified administrative functions including Trial Master File set-up and maintenance.

The CTS/Senior CTS works closely with project team to help manage clinical trial feasibility processes, coordinate clinical trial start-up activities including collection of essential documents for site initiation/startup, submissions to central IRBs and local EC. Senior CTS maintains contact with sites according to Project Management Plan and/or Clinical Trial Monitoring Plan by maintaining contact information and providing guidance to the sites, keeping site files current for the George Clinical trial master file, and coordinating communication between CRAs, CTMs and PMs. The Senior CTS is responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.

Key Accountabilities :Assists in coordination of feasibility process with activities that could include the following:Identifies site list for blinded and un-blinded feasibilities as requestedManage distribution, collection, and tracking of signed CDAs when appropriateMaintains database of site information from feasibility questionnairesProvide ongoing reports and updates to the project team during feasibility process according to required timelines and project deliverablesWork with PM/CTM to develop final reports and recommendations of sites for Qualification VisitsProvides ongoing site management to ensure project completion within designated timelinesWorks with projects managers to provide support to sites to facilitate accruals to studiesMaintains database of accruals for each study and siteContacts study sites on a regular schedule to obtain feedback on study procedures and identification of site-specific problemsAddress and/or triage questions from the sites and record site communication as per SOPs and/or project plansMaintain consistent communication with CRAs and PM regarding site updates and communicationEstablish and maintain the Trial Master File (TMF) via hard copy and/or shadow or eTMF as assigned by project.Upload and maintain TMF files and folders in George Clinical’s file-sharing system by project, as assigned.Collect essential documents from sites on designated scheduleEthics/IRB Submissions ,Prepare Central Study level Ethics/IRB submissionPrepare and submit site Ethics/IRB submission packages ,Manage Ethics/IRB submissions as applicableReview, confirm accuracy of approved Ethics/IRB documentsEssential Documents – Site StartupCollect Essential Documents from site during site startupCompile / prepare Essential Document Package (EDP) for regulatory readinessSubmit final EDPs to sponsor or PM/CTM as requiredServe as second reviewer (QC) of EDP for fellow CTSReview Informed Consent Forms as neededSetup and manage Study Portal, as needed/if applicableSetup and manage trackers as assigned by PM/CTMInterfaces internally with other departments as needed, including but not limited to, Data Management, Monitoring, and FinanceInterfaces externally with study sponsors, vendor and study sitesRecord meeting minutes as needed by PM teamProvide ongoing support for PM/CTM to help develop and/or maintain assigned forms, logs, or other site materialsAssemble and prepare shipments for site study materialsProvide data entry support for the investigator payment database by project, as assigned and with input from appropriate PM/CTM.

What are our expectations of candidates?Tertiary qualifications in a related science or health care discipline4 - 8 years of experience as clinical trial specialistExposure to medical terminology and physiologyExposure to ICH/GCP, ethical and regulatory requirementsExcellent interpersonal skills, presentation skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholdersExcellent organisational skills – ability to organise, take initiative and follow up independentlyTechnological proficiency including Microsoft Office packagesAbility to see the big picture, yet still focus on detail and quality of workAbility to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments

We are searching for individuals who are excited by the idea of regional and global projects and teams, don’t want to get lost in a large CRO and are ready to have their ideas heardYou will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.

How do I apply and what if I'm interested in a role in future or want to refer someone?Apply via LinkedIn or send your CV, referral or confidential query

to

and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

How do I learn more about the roles and George Clinical?Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects You can also visit us atWe are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

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