Job Description

Clinical Data Manager (CDM) Neurona Therapeutics is an early-stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and take part in building an exciting, science-driven company. The clinical data manager (CDM) manages clinical trial data collection, processing and analysis of Neurona clinical trials. They play a critical role in developing new medical treatments by ensuring that clinical trial data is accurate, complete and compliant with regulatory requirements. The CDM works closely with other clinical research team members, including clinical trial leads, in-house CRAs, biostatisticians and CRO - to ensure that all aspects of the data management process are executed efficiently and accurately. The key responsibilities of the CDM include designing and implementing clinical data management plans, developing data entry guidelines and standards, overseeing data quality control processes, design of case report forms (CRFs) and oversee electronic data capture (EDC) systems to facilitate efficient data collection. The CDM will also collaborate with study and research teams to address data-related issues promptly and generate accurate data summaries and reports. The CDM tracks and ensures timely site data entry, issues Sponsor queries, and tracks all queries to resolution. The CDM may assist in ensuring required imaging and EEGs are uploaded in a timely manner to Sponsor portals. The CDM verifies the data management activities of their assigned study(s) are in accordance with Neurona Therapeutics' policies and procedures, ICH/GCP, and local regulations to ensure data integrity and compliance throughout the clinical trial lifecycle. The CDM will report directly to the Director of Clinical Operations. Responsibilities include:

• Develop data management documentation with CRO, including case report forms and data management plans.
• Design case report forms (CRFs) and manage electronic data capture (EDC) systems for data collection, including

builds and User Acceptance Testing (UAT).

• Perform data entry and cleaning activities, including discrepancy management and query resolution.
• Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
• Develop and execute standard operating procedures (SOPs) and work instructions (WIs) for in-house data

management activities.

• Collaborate with study team members to resolve data-related issues and discrepancies.
• Manage and quality check all data tables, listings and figures (TLFs), summaries and reports for DSMB meetings,

investor meetings, publications, analysis, and agency submissions

• Manage data cuts, data freeze and database locks
• Manage Sponsor managed data contracts and data transfer agreements with outside vendors
• May manage and ensure timely upload of MRI/MRS imaging and EEGs in required format
• Assist with generation of queries related to imaging and EEGs
• Coordinate data reviews to and from Neurona consultants and advisors
• Ensure MEDDRA and WHODRUG coding activities are performed on time and consistency in coding
• Track and ensure site data is entered in timely manner
• Proactively identify and communicate site data entry and upload performance to key stakeholders and implements

action plans in conjunction with the Clinical Trial Leads

• Serve as a primary or backup resource for issues about data management.
• Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
• Contribute to the identification, development and validation of data management software tools.

Required Qualifications:

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical

research industry

• 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 GCP, GDP, GCDMP and CDISC standards
• Knowledge of industry-standard data analysis and reporting software, such as SAS
• Strong organizational and time management abilities
• Excellent attention to detail with problem-solving and analytical skills
• Excellent writing, verbal communication, presentation, and interpersonal skills
• Strong multi-tasking skills
• Flexibility with changing priorities
• Work effectively both independently and as part of a team
• Proficiency in MS Office, Google mail, BOX, SharePoint, other similar systems
• Ability to travel up to 10% nationwide

Preferred Qualifications:

• Experience in cell therapy trials
• Experience partnering with CROs
• Certification in clinical data management (like CCDM).
• Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM)
• Understanding of data privacy and protection regulations (e.g., GDPR)
• Experience with Merative Zelta EDC
• Data science, data analytics, and/or data visualization experience preferred
• ACRP, SoCRA or equivalent certification

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are aware of active recruitment scams using the Neurona name, where individuals pose as our recruiters or post fake remote job openings and make fraudulent job offers online. Please note, that we will never make an offer of employment without conducting multiple rounds of face-to-face interviews using secure video-conferencing technology. Additionally, we will never ask candidates to cash checks or make any payment to be considered for a position. If you believe you have been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency (CISA) at to learn how to report it. Neurona Therapeutics

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