- Performs the startupactivities of assigned studies within a country or region ensuringthat those are performed ontime within the scope and in compliancewith ICH/GCP guidelines SOPs and protocolrequirements.
- Collect review approve processand track regulatory & investigator documents required forstudy site activation.
- Prepare and completeregulatory process (IEC/IRBs) including ask for requirements to theEC/IRBSs prepare and collecting specific documentation submissionand amendments regulatory fees.
- Collaboratewith Regulatory department regarding HA/CAsubmission/notification.
- Main responsible ofensuring the quality control of documentation included in anysubmission/notification.
- Adapt Informed Consentdocuments according to local law and document the process followingguidelines and SOPs.
- Ensure contracts are fullyexecuted regulatory documents and approvals are granted IP Releaseauthorized and specific project deliverables arecompleted.
- Bachelors Degreepreferred
- Good knowledge of GCP/ICHguidelines
- Good Knowledge of applicableregulatory requirements SOPs and companys CorporateStandards
- Minimum 13 years of relevant clinicalexperience
- Previous experience withinvestigator startup documents and investigative sites ispreferred
- Good written and communication skillsin English and Czech
- Good organizational skillsand experience working with cross functionalteams
- Strong software and computerskills
- Capable of multitasking and working wellunder pressure to meet deadline coupled with a good understandingof working in a team environment
- Travel withinthis position islimited
Study Start-Up Specialist - Lund, United Kingdom - TFS HealthScience
Description
TFS HealthScience is a leading global midsizeContract Research Organization (CRO) that partners withbiotechnology and pharmaceutical companies throughout their entireclinical development journey. Our expertise includes fullservicecapabilities resourcing and Functional Service (FSP)solutions.
JoinOur Team as aStudy Start Up Specialist home based inCzech.
About thisrole
As part of ourStudy StartUp team you will working alongsidepassionate and innovative professionals to ensure our customersachieve their goals.
The StudyStart Up Specialist is part of the Site Managementand Start Up Unit within TFS Develop and will functionoperationally as a member of a Project Team being responsible ofstartup activities according to company policies SOPs andregulatory requirements in addition to financial and contractualobligations.
The Study Start UpSpecialist must contribute to ensure the plannedstart up plan is executed maximizing the recruitment window ofassigned studies. As part of the job function will performactivities associated with feasibility and site identificationstudy site initiation process interact with Ethics Committees ordeal with investigator contracts.
KeyResponsibilities:
Qualifications:
WhatWe Offer
We provide a competitivecompensation package comprehensive benefits and the opportunity forpersonal and professional growth in a rewarding environment. Youllbe joining a team that values collaboration innovation and making adifference in the lives ofpatients
A Bit More AboutUs
Our journey began over 25 yearsago in Sweden in the city of Lund. As a global CRO with theultimate goal of ensuring patients safety and wellbeing we providebiotechnology and pharmaceutical companies with tailored clinicaldevelopment solutions. We currently operate in 17 countries acrossEurope North America Asia Pacific and the Middle East.
Our core values of Trust Quality Flexibility andPassion are what make TFS Healthscience the successful company itis today. Our values shape our culture and work ethic. They reflectwhat we stand for and guide ourorganization.
#Together we make adifference