CTA Study Start-up Specialist
Do you want to work for a Global Pharmaceutical company where you will get recognized for your hard work and commitment? Look no further, apply today. CTA Study Start-up Specialist, Novartis, Czech Republic.
The CTA Study Start-up Specialist is accountable for performing start-up activities and other activities during performing clinical studies of phase I-III, global phase IV for a country or cluster, from but not limited to planning and site feasibility to prepare study site for Initiation Visit in compliance with Novartis processes and regulatory requirements.
• Attend study team meetings as required, including Kick-Off Meetings which are mandatory
• support feasibility and site identification/selection, as assigned
• Active communication with Clinical Trial Team (CTT)
• Liaise with CSM, study sites regarding essential document collection and assisting with IRB/EC submissions
• Prepare, review and submit submissions to HA (resp. CTA Hub), EC in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• This includes, but it is not limited to:
o ethics/regulatory/other relevant authority approvals for clinical trials
o ethics/regulatory/other relevant authority approvals for trial amendments
o ethics/regulatory/other relevant authority study notifications
• Responsible for the translation and co-ordination of translations for documents required for submission
• Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the clinical trial management system
• Copy and route incoming correspondence, internal documentation, etc., as appropriate
• Responsible for the collection of critical documents required for IP Release
• Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as ap-propriate
• To be familiar with ICH GCP, relevant country regulations/guidelines and Novartis opera-tion and working procedures
• Competent in communication skills for timely follow-up, issue resolution and report up-dates; as outlined in the communication and escalation plan with timely documentation
• Reporting of spontaneous AE reports and technical complaints for all Novartis products
• iPortal and other safety nofitications (ex. DSUR) handling
• activities regarding iRelease for Trial Monitoring
• other activities for CTA position as per local processes upon Country Clinical Trial Moni-toring Head
About Novartis Innovative Medicine:
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. We apply our expertise in science and innovation to society’s biggest health challenges. Responsibility is a core part of our business strategy.
The Innovative Medicines Division has two business units:
Novartis Pharmaceuticals commercializes innovative, patented primary care and specialty medicines to enhance health outcomes for patients and health-care providers.
Novartis Oncology commercializes a portfolio of patented oncology, hematology and rare disease medicines to address the medical needs of people with cancer and related diseases.
Benefits of Working for Novartis:
Strong work/life balance, flexible working hours
Pension/risk life insurance scheme
5 weeks paid holiday
Cafeteria employee benefit program
Public transportation allowance
Plus additional benefits
‘I came for the job, I stay for the culture’
Ideal candidate profile
The ideal candidate will have:
Minimum degree acceptable: University Degree, also bachelor’s degree is sufficient
Desirable degrees: University Degree in Nature Sciences
Languages: English – fluent, spoken and written
Required experience and skills:
• Ideally 2 years’ strong experience in clinical research
• Strong Interpersonal skills
• Strong Project Management skills
• Working experience in a global team, team player
• Ability to work under pressure