Trial Data Manager
Vor 6 Tagen
**Trial Data Manager - 5844 URA**
Our client is headquartered in Switzerland - a biotech-hub of Europe - is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking a **Trial Data Manager** for a initial 12 months **contract** based in **Basel area.**
**Main Responsibilities**:
- Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Company Standards, and applicable regulations
- Meets study timelines in terms of Data Management deliverables
- Ensures data handling consistency within allocated study(ies)
- Leads Data Management activities for assigned study
- Provides Data Management input to the development of the study protocol
- Coordinates the development of the (e)CRF in line with Company standards
- Writes all study Data Management documents covering specifications for external data transfer, data cleanings and review tools that will be further provided to Data Management Programmer(s) for development for the allocated study(ies)
- Organizes, monitors and tracks the testing of data entry screens (eCRF 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 study metrics and status reports
- Represents Data Management at Clinical Trial Team (CTT) meetings
- Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners’ management)
- Prepares and archives Data Management study documentation
- Presents study related topics at CTT, Investigators and Monitors meetings
- 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
- Forecasts study team resource requirements
- Ensures Data Managers assigned to study have required training
- Ensures Study Data Tabulation Model (SDTM) deliverables (Including SDTM datasets, define.xml and annotated CRF) are created, validated and provided as per agreed timelines
- Performs and/or coordinates Quality Control (QC): Periodic operational checks to verify that clinical data are handles according to protocol, applicable Quality System (QS) documents and GCP
- Work is expected to be performed on the premises of Company
- Acts as Data Manager for studies where no DM is assigned
**Qualifications and Experience**:
- **_Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;_**
- Recognized degree in life sciences, mathematics, statistics, informatics or related disciplines
- At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical
- Data Management with good level of functional expertise in Data Management
- Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization - Good Clinical Practice (ICH/GCP))
- Ability to lead and coordinate the activity of Data Manager(s) allocated to his/her study
- Good organizational and presentation skills
- Fluent in written and spoken English
-
Clinical Trial Lead
vor 2 Wochen
Basel, Schweiz Source Group International VollzeitXplore Life Science are currently seeking an experienced Clinical Trial Leader to oversee the planning an implementation of a new study conducted by a class leading pharmaceuticals company based in Basel, Switzerland. Duration of assignment is approx 18 months with potential for extension. Major Accountabilities: - Function as Clinical Trial Leader for...
-
Director, Clinical Trial Management
vor 2 Wochen
Basel, Schweiz Proclinical VollzeitProclinical are searching for a highly experienced and innovative Director of Clinical Trial Management to join our client, a clinical-stage biotech organisation specialised in radio-immune therapies. Report into: Head of Clinical Operations **Responsibilities**: - Develop and implement clinical trial processes and procedures to ensure compliance with...
-
Data Manager
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Warman O'Brien VollzeitJob Title:Data Manager (Contractor)Location:Basel, SwitzerlandStart Date:Q1 2026Contract Type:ContractorAbility to Work:Swiss National or valid work permitAbout the Role:We are seeking an experiencedData Managerto support the SOS-AMI (Selatogrel) study. This is a critical role focused on ensuring data quality during a period of increased recruitment and a...
-
Clinical Trial Leader I
vor 1 Woche
Basel, Schweiz Novartis Vollzeit6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients! Based on our understanding of cancer at the molecular, cellular and organismal levels,...
-
Clinical Data Manager
vor 23 Stunden
Basel, Basel-Stadt, Schweiz Planet Pharma VollzeitPlanet Pharma is seeking a Clinical Data Manager to work for a company in Switzerland.As a Data Manager, you will play a key role in ensuring the integrity and quality of clinical data. Your responsibilities will include:Ensuring all Data Management activities adhere to internal standards and regulatory requirementsSupporting the development and testing of...
-
Clinical Trial Manager
Vor 2 Tagen
Basel, Schweiz Universal-Job VollzeitIn this role you define and execute an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients. You are responsible for: - Define and advise the iCTT on the optimal clinical trial supply strategy in terms of packaging design, technical and timeline feasibility, efficiency and...
-
Clinical Data Lead
vor 2 Wochen
Basel, Schweiz headcount VollzeitAbout the RoleWe are seeking an experienced Clinical Data Lead to join our team in Basel, to oversee clinical data management for ongoing and upcoming trials. You will take responsibility for data management strategy, execution and delivery — from database build to final database lock — ensuring data quality, compliance and timely delivery to...
-
Associate Clinical Trial Supply Manager
Vor 2 Tagen
Basel, Schweiz Aequor Consulting GmbH VollzeitFor one of our international well-known Swiss pharmaceutical clients we are looking for a highly motivated Associate Clinical Trial Supply Manager (m/w/d) in Basel. **Your Responsibilities** - Represent GCS(Global Clinical Supply) as a core member in the integrated Clinical Trial Team (iCTT); define and advise the iCTT on the optimal clinical trial supply...
-
Data Manager
vor 21 Stunden
Basel, Basel-Stadt, Schweiz Apsida Life Science VollzeitJob Title: Data ManagerLocation: Basel, SwitzerlandSchedule: Full-TimeDuration: 24 monthsCompany Overview:Apsida Life Science is currently partnering with a dynamic biopharmaceutical company based in Switzerland, dedicated to discovering, developing, and bringing more effective therapies to patients. This organization is driven by a strong science-based...
-
Senior Clinical Trial Associate
Vor 7 Tagen
Basel, Schweiz headcount VollzeitOverviewThe Senior CTA supports operational and development activities across assigned clinical studies. This role ensures efficient study execution, high-quality documentation, and effective oversight of CRO vendors and other operational partners. This is a long term contract role to be based in Basel (Hybrid).Key Responsibilities Support study start-up...