Study Scientist / Clinical Trial Application (m/f/d)
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Bern |
Temporary Employment
Job title: Study Scientist / Clinical Trial Application (m/f/d)
Industry: PharmaSkills: Clinical Trial Application, Regulatory Affairs, Clinical Research
Start of project: 15.03.2022
Duration of the project : 8 Months
Project volume: 1344 Hours
Location: Bern / Homeoffice
Tasks:
Contribute to CTA activities for global clinical trials during the entire study lifecycle under supervision of the GRSL
- Prepare, compile and submit country-specific CTA dossiers in selected countries
- Interact with other GRA functions as well as with key functions within Clinical Research and Development, Clinical Operations, Global Clinical Safety & Pharmacovigilance, Clinical Trial Supply, pre-Clinical, Legal Affairs and CRO) and organize the timely and effective generation of CTA documents to ensure CTA submission is performed on time and with high quality documents
- Prepare core CTA dossier and/or control the quality of the core CTA dossier
- Oversee preparation of country-specific CTA dossiers and ensure consistency with core CTA dossier
- Disseminate the CTA project status like CTA submission, CTA approval, CA questions to the concerned stakeholders
- Ensure accurate and timely tracking and archiving of CTA activities
Maintain and improve CTA processes related to CTA activities. Contribute to development and improvement of systems and solutions related to CTA activities:
- Maintain and improve processes, procedures and systems which support the global management of CTAs
- Share lessons learned within the team
- Participate in or co-chair the CTA regulatory meetings as per the standard operating procedure.
- Participate in Global Regulatory Strategy Team (GRAST) and Study Execution Team (SET) meetings, as appropriate
- Under the supervision of the GRSL, management and oversight of First Service Provider (FSP) and Contract Research Organizations (CROs) performing CTAs to ensure quality, timely approvals, and compliance. Ensuring synergies/lessons learned are used to improve CTA approval processes and timelines
Act as a back-up for the GRSL who is the primary point of contact for stakeholders outside of GRA (Clinical Research and Development, Clinical Operations, Global Clinical Safety & Pharmacovigilance, pre-Clinical, Commercial Operations, Project Management, Quality Assurance, Legal Affairs) for CTA specific information
Become a Subject Matter Expert for CTA-related topics:
- Keep abreast of new CTA requirements, regulations and guidance documents
- Ensure CTA Operations readiness for the implementation of new CTA regulations, e.g. EU CTR
- Maintain a CTA knowledge database with up to date information on ongoing and past clinical trials (e.g. countries benchmarking, list of questions, submission requirements, etc.)
- Ensure standard processes, tools and procedures are used consistently for CTA process.
- Collect in-house benchmarking information, perform tracking of regulatory CTA metrics and KPIs for key activities
Qualifications:
- 3 years of Apprenticeship, e.g. as Medicinal Documentation Professional or equivalent
- As a guide, a minimum of 3+ years’ experience in Regulatory Affairs or Clinical Research, preferably with experience in managing Clinical Trial Authorizations
- Knowledge of regulatory requirements in key markets for obtaining Clinical Trial Authorizations
- Knowledge of ICH guidelines/GCP and current medical/scientific/regulatory knowledge
- Customer service focus
- Good project management as well as planning, time management & coordination skills to meet deadlines
- Excellent written and oral communication skills in English – German is a plus
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Yannik Nies
y.nies@aristo-group.ch
+41 44 274 39 00
11051
Pharma
15.03.2022
8 Months
Temporary Employment
