Auf einen Blick
- Aufgaben: Leite die Datenmanagement-Aktivitäten für klinische Studien und stelle die Einhaltung von Standards sicher.
- Unternehmen: Innovatives biopharmazeutisches Unternehmen mit Sitz in der Schweiz.
- Vorteile: Attraktives Gehalt, flexible Arbeitszeiten und Entwicklungsmöglichkeiten.
- Weitere Informationen: Dynamisches Umfeld mit hervorragenden Karrieremöglichkeiten.
- Warum dieser Job: Gestalte die Zukunft der Medizin und mache einen echten Unterschied für Patienten.
- Qualifikationen: Masterabschluss in Lebenswissenschaften und 5+ Jahre Erfahrung im Datenmanagement.
Das prognostizierte Gehalt liegt zwischen 60000 - 80000 € pro Jahr.
The Life Science Career Network is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997.
We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
Our client, a high‑potential biopharmaceutical company headquartered in Switzerland, is specialised in the discovery, development and commercialization of innovative small molecules and is looking for a Senior Trial Data Manager for a 24‑month contract based in the Basel area.
This position will lead the local medical team, ensure alignment and execution of local/regional medical strategy, collaborate with cross‑functional teams and influence key healthcare stakeholders to drive meaningful impact for patients and the business.
Main responsibilities Ensures Data Management activities related to assigned trial adhere to the company`s standards, applicable regulations.
Meets trial timelines in terms of DM deliverables and ensures data handling consistency within allocated trial(s).
Lead DM activities for assigned trial.
Provides DM input to the development of the trial protocol.
Coordinates the development of the (e)CRF in line with the company`s standards.
Writes all trial Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to DM PROGRAMMERS for development for the allocated trial(s).
Prepares and archives Data Management trial documentation.
Organizes, monitors and tracks the testing of data entry screens (e CRF layout), data cleaning / review tools, and their implementation in the production environment.
Organizes, monitors and tracks data cleaning, data review, query management, and database lock; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders.
Generates trial metrics and status reports.
Represents Data Management (Biometry) at Clinical Trial Team (CTT) meetings.
Presents (as needed) trial related topics at CTT, Investigators and Monitors meetings.
Manages and is accountable for Data Management activities in studies where DM outsourced (insourcing/outsourcing partners’ management).
Participates in development and review of policies, Standard Operating Procedures (SOPs), and associated documents for Data Management.
Represents Data Management in cross-functional working groups related to the system /process.
Handles External Vendors, including participation to vendor selection (BID defense attendance, RFP and budget reviews), and vendor oversight.
FSP (if applicable) monthly invoices check and FSP team members onboarding and trial related training.
Forecasts trial team resource requirements.
Sets annual goals and appraises performance of direct reports.
Ensures DATA MANAGER(S) and TRIAL DATA MANAGER(S) assigned to trial has/have required training.
Ensures annotated CRF is created, validated, and provided as per agreed timelines.
Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handled according to protocol, applicable Quality System (QS) documents and GCP.
Acts as DATA MANAGER for studies when no DATA MANAGER is assigned.
Qualifications and Experience Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required; A master’s degree in life sciences, mathematics, statistics, informatics or related disciplines is required. 5+ years of experience in pharmaceutical or Biotech industry within Clinical Research and/or Clinical Data Management with a strong level of functional expertise in Data Management is required.
Strong organizational and communication skills in English.
Good knowledge of international clinical research regulations and requirements (e. g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP)).
Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design.
Ability to lead and coordinate the activity of DATA MANAGER(S) allocated to the same trial.
Good organizational and presentation skills.
Fluent in written and spoken English. #J-18808-Ljbffr
