Clinical Data Manager (CDM)

Description
Function
Clinical Data Manager (CDM)
Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben 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

Job description other vendors, under the supervision of the HCO, for ensuring appropriate data collection, validation and processing of clinical data generated during AC Immune's clinical studies. Moreover, CDM will ensure/verify that data received at AC Immune (own clinical data or external clinical sources) are complete and accurate and handled appropriately. Key Responsibilities

• 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)

Qualifications & Skills
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,

FDA/CFR and CDISC standards.

• 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