Clinical Data Manager (CDM)
Description
Function
Clinical Data Manager (CDM)
Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne Write an email Percentage
100 %
Reporting Line
Head of Clinical Operations (HCO) Company Profile
Required:
Function
Clinical Data Manager (CDM)
Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne Write an email Percentage
100 %
Reporting Line
Head of Clinical Operations (HCO) Company Profile
- AC Immune is a clinical stage Swiss biotech company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases
- 150+ Employees, 20+ nationalities, IPO in 2016, listed on NASDAQ
- AC Immune SA is a progressive, equal opportunity employer The Clinical Data Manager will oversee the activities of the clinical CRO and
- Develop and implement data management procedures for clinical studies
- Review data management documentation, including study protocols, case report forms and data management plans
- Test electronic data capture (EDC) systems for data collection
- Oversee data entry and cleaning activities, including discrepancy management and query resolution
- Collaborate with study team members to resolve data-related issues and discrepancies
- Serve as a primary contact for data management activities, internal as well as with clinical CRO
- Support and facilitating the review of medical coding for validity and completeness
- Ensure/verify quality of clinical data from AC Immune clinical studies as well as from external sources (e.g. datasets from registries)
Required:
- Bachelor's degree in a scientific or healthcare-related field.
- 3-5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
- Good spoken and written English Personal features include:
- Strong understanding of clinical trial processes, data management principles and regulatory guidelines
- Proficiency in electronic data capture (EDC) systems and clinical data management software.
- Familiarity with relevant regulations and guidelines, like ICH/GCP,
- Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
- Excellent attention to detail with problem-solving and analytical skills
- Strong organizational and time management abilities Would be a big plus:
- Has worked in the implementation of data management activities at a sponsor
- Has worked for a biotech company
Über die Firma
CH-1015 Lausanne / Lausanne
