Berufsbezeichnung:
Lab Professional, QA/QC Professional/Associate Scientist Bio Arbeitsort: Basel

Arbeitsbeschreibung:
For assigned General Medicine Global trials: ¿Responsible for the end-to-end Quality Control of essential TMF documents for assigned trials/programs according to established timelines. ¿Oversight of TMF Quality Control Specialists ¿Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team (CTT) for TMF related questions Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms Major Activities (Describe 8-12 main activities) Responsible for the end-to-end TMF Quality Control (QC) at the Headquarter, Country and site levels: ¿Serve as Subject Matter Expert on TMF Quality Control ¿Translate trial information, processes and regulations into TMF documentation ¿Responsible for conducting specified quality controls on some essential clinical documents according to established processes. ¿Track progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations. Oversight of TMF Quality Control Specialists ¿Monitor Quality Control performed by the TMF QC specialists on assigned trials ¿Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/Quality Control Single Point of Contact to the CTT for their assigned trials ¿Accountable for generating and managing the TMF Filing plan and TMF QC Reports ¿Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content) ¿Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions ¿Proactively ¿pull¿ information during the set-up, execution, and close-out phases from accountable CTT members. ¿Participate in CTT meetings as needed ¿Monitor the CTT compliance with TMF process within a trial in a timely manner ¿Contact point to secure access to eTrack system Responsible for optimizing, maintaining, and rolling out TMF training mechanisms ¿Serve as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical document management system, user Manuals for eTrack) ¿Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF governance board, TMF QC Compliance Review Meeting). ¿As a TMF Center of Excellence representative, may participate in global cross-functional business process performance or clinical development improvement initiatives. ¿Responsible for the training of CTTs on TMF and implementation of best practices within CTTs ¿Participate in the on-boarding, mentoring and training of new staff. Key Performance Indicators (Indicate how performance for this job will be measured) Timely, accurate and complete TMF Table Of Content according to trial timelines: Ready to Initiate Site (RIS); Close Out Visit (COV); End Of Trial (EoT). Impact on the organization: Accurate and complete program/trial information in Document Management System according to established timelines allowing for: ¿Increased quality of Trial Master Files (TMF) ¿Decreased audit/inspection findings ¿Increased compliance with TMF SOP/training, and GCP. Ideal Background (State the preferred education and experience level) Education (minimum/desirable): Bachelor¿s degree in life science/healthcare is required with minimum 4 years¿ experience in clinical operations and / or clinical systems management or Associate degree required with minimum 6 years¿ experience in clinical operations and / or clinical systems management Languages: Fluent English (oral and written) - Geforderte Anlagen: Lebenslauf, Zeugnisse

Angestelltenname: ELAN Personal AG

Arbeitgeber-Adresse: Leimgrubenweg 16, CH-4053 Basel, Schweiz

Form von Kontakt: Mara Slongo

Arbeitgeber Telefonnummer: +41 61 3363333

Arbeitgeber Faxnummer: +41 61 3363339

Stellenkurzbeschreibung: Chemiker

Land: Schweiz

Region: SCHWEIZ/SUISSE/SVIZZERA

Vertragslaufzeit: Unbefristet

Vertragstyp: Vollzeit

Erforderliche Ausbildung: Keine Angabe

Quelle des Stellenangebots: BA, Öffentliche Arbeitsverwaltungen, Deutschland

Wie Sie sich bewerben: Weitere Angaben (siehe Beschreibung)

Gehalt Währung: EUR

Gehaltsperiode: monatlich

Gehalt Besteuerung: brutto