Trial Data Manager

vor 2 Wochen

Basel, Schweiz CTC Resourcing Solutions Vollzeit

**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

  • Associate Global Trial Director

    Vor 5 Tagen

    Basel, Schweiz Manpower Vollzeit

    Mandated by one of our client companies, we are currently looking for an Associate Global Trial Director (AGTD). **General information** Workload: 90% - 100% Starting date**:ASAP,** as of June 1st Termination 31.12.2023 On-Site position Remote: to be discussed over interview - mandatory 3 days per week on site **Your mission** **Major...

  • Clinical Trial Supply Manager

    Vor 4 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client is a biotechnology company, developing next generation cancer vaccines based on viral vector technologies. We are currently looking for a **Clinical Trial Supply Manager** for a contract role, fully remote, for applicants living in Switzerland. Your responsibilities include conducting and overseeing all supply...

  • Digital Biomarker Data Solution Manager

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Digital health technology is transforming the way we develop personalized medicines for patients. Roche is dedicated to creating community- and regulator-accepted digital endpoints and digital outcomes that redefine the way we measure disease progression in clinical drug trials and make them accessible to Biopharma companies and the...

  • Innovation Capability Head

    vor 4 Wochen

    Basel, Schweiz Novartis Vollzeit

    100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO- You will partner with Portfolio Innovation Directors to understand future portfolio needs and proactively...

  • Genetics and Genomics Data Manager

    Vor 4 Tagen

    Basel, Schweiz Manpower Vollzeit

    Patient - Sample - Assay - data is preferred. Working with global CROS / vendors / central labs is preferred. **Tasks & Responsibilities**: - Support ingestion of High dimensional Genomic and Genetic data on studies - Work with gRED colleagues/PS BioX GnG scientists, CROs/Vendors to pre-align on data transfer requirements (e.g. Metadata requirements) -...

  • Digital Biomarker Clinical Integration Manager

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Job Mission We, the Digital Biomarker (dBM) Chapter in Roche Information Solutions, are an integrated team of scientists, technologists, data analysts and operationalization experts, that leverages mobile technologies like smartphones and wearables to collect objective and continuous sensor data from patients in clinical trials.  We...

  • Data Manager in 80-100% Departement Klinische

    vor 4 Wochen

    Basel, Schweiz Universitätsspital Basel Vollzeit

    Das Universitätsspital Basel ist eines der führenden Spitäler der Schweiz. Durch die enge Zusammenarbeit mit der Universität Basel und die Nähe zu global führenden Life-Science-Unternehmen sind wir Teil eines innovativen Wissenstransfers auf Spitzenniveau in Forschung, Lehre und Patientenversorgung. Unsere rund 7'100 Mitarbeitenden aus 86 Nationen...

  • Digital Biomarker Workflows Solution Manager

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Digital health technology is transforming the way we develop personalized medicines for patients. Roche is dedicated to creating community- and regulator-accepted digital endpoints and digital outcomes that redefine the way we measure disease progression in clinical drug trials, and make them accessible to Biopharma companies and the...

  • Data Scientist

    Vor 5 Tagen

    Basel, Schweiz Hobson Prior Vollzeit

    **Salary**: CHF40 - CHF50 per hour**Job type**: Interim/Contract **Location**: Basel, Switzerland **Function**: Biometrics, Data Science & Biometrics **Posted**:12/06/2023 **Ref**: BBBH22666 - Hi I'm Graeme , I manage this role Hobson Prior are currently looking for a Data Scientist to join a brilliant pharmaceutical organisation on a contract basis...

  • Digital Biomarker Data Management Architect

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Digital health technology is transforming the way we develop personalized medicines for patients. Roche is dedicated to creating community- and regulator-accepted digital endpoints and digital outcomes that redefine the way we measure disease progression in clinical drug trials and make them accessible to Biopharma companies and the...

  • Commercial Packaging and Clinical Trial Supplies

    vor 4 Wochen

    Basel, Schweiz CK Group Vollzeit

    **Salary**:77.96 CHF per hour - **REF Number**:v-99333 - **Consultant**:Karen Kangley - **Contact**:01246 457733 - **Date Published**:17.04.2024 - **Industry**:Pharmaceutical - **Location**:Basel, Switzerland - **Functional Expertise**:Clinical Operations/Development CK Group are recruiting for a Commercial Packaging and Clinical Trial Supply Manager to...

  • Clinical Trial Associate

    vor 4 Wochen

    Basel, Schweiz Noema Pharma Vollzeit

    Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks. At Noema Pharma, every patient matters. Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes. We partner with...

  • Clinical Trial Associate

    vor 4 Wochen

    Basel, Schweiz Noema Pharma Vollzeit

    Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks. At Noema Pharma, every patient matters. Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes. We partner with...

  • Clinical Trial Associate

    vor 3 Wochen

    Basel, Schweiz Noema Pharma Vollzeit

    Noema Pharma is a clinical-stage biotech company targeting debilitating central nervous system (CNS) disorders characterized by imbalanced neuronal networks.At Noema Pharma, every patient matters.Our pipeline contains novel therapies designed to address debilitating CNS disorders in order to improve quality of life and patient outcomes.We partner with...

  • Digital Biomarker Device Operations Manager

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Digital health technology is transforming the way we develop personalized medicines for patients. Roche is dedicated to creating community- and regulator-accepted digital endpoints and digital outcomes that redefine the way we measure disease progression in clinical drug trials, and make them accessible to Biopharma companies and the...

  • Intern - Data Standards & Governance / Data Privacy & Sharing

    vor 3 Wochen

    Basel, Schweiz Roche Vollzeit

    The Position Position Summary As an intern in Data Strategy & Delivery in PD Data Sciences you will spend your time equally between two groups: you will be embedded in both the 1. Data Standards and Governance (DSG) and 2. the Data Privacy & Sharing (DPS) Enabling Platforms (EP). This internship position will drive the design, implementation and...

  • Delivery Manager

    Vor 4 Tagen

    Basel, Schweiz Arcondis Vollzeit

    ABOUT ARCONDIS Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes, information technology, and...

  • In Vitro Regulatory Reporting

    vor 4 Wochen

    Basel, Schweiz ITech Consult Vollzeit

    **In vitro regulatory reporting & data manager for New Approach Methodologies (M/F/d) - GxP / project management / stakeholder management / data management and digital workflows / regulatory requirements/environment / English** **Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified In vitro regulatory...

  • BASEL OFFICE

    vor 3 Wochen

    Basel, Schweiz Viking Vollzeit

    Viking was founded in 1997 and provides destination-focused voyages on oceans, rivers and lakes around the world. Designed for experienced travelers with interests in science, history, culture and cuisine, Chairman Torstein Hagen often says Viking offers experiences for The Thinking Person®. Viking has more than 250 awards to its name, including being...

  • Intern Data Governance Manager

    vor 4 Wochen

    Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel**Intern - Data Governance Manager**: Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our...