Associate Director/Sr. Manager, Clinical Data Management (SSF, CA or Remote)

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of thecal complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.

Desired Candidate Profile

The Associate Director/Sr. Manager,  Clinical Data Management (CDM) will work collaboratively in a fast-paced, cross functional team environment. We are seeking a highly motivated individual to join our dynamic Biometrics department.  This individual will play a key role in ensuring accurate, high quality clinical trial data.  Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in support of trial objectives and corporate goals. This position will report to the Director or Senior Director CDM. 

Specific Responsibilities

• Provide a high level of expertise in Data Management (DM) to support clinical studies.
• Ensure that data quality and integrity are maintained from study start through database lock.
• Lead the design of CRFs/eCRF for sound and thorough data collection through the regulatory approval process.
• Lead data review, query management, and data management metrics reporting to ensure completeness, correctness, and consistency.
• Assume data management responsibility for multiple clinical trials, including specification and testing of the Electronic Data Capture (EDC) and other data collection systems.
• Author and maintain data management documents including Data Management Plans, Data Transfer Plans, and Data Review Plans.
• Review study protocols and assist in the planning and implementation of the data management portions.
• Data Management Lead for assigned clinical studies.
• Serves as an active member of Clinical Study Teams (CST).
• Works with other functions to develop timelines and ensure that clinical data management deadlines are met.
• Oversees DM CROs as applicable.
• Works with vendors such as central laboratories in support of timelines and data-related deliverables.
• Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
• Defines eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol.
• Works closely with database builders during programming of EDC databases, edit checks and reports.
• Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications.
• Develops study-specific eCRF Completion Guidelines.
• Creates and follows study-specific Data Management Plans.
• Creates and maintains data management documentation.
• Ensures data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
• Works with the appropriate coding group to ensure medical terminology coding is applied to assigned clinical studies.
• Helps design listings in support of clinical and medical review of data.
• Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members.
• Trains other personnel on eCRFs and EDC, as needed.
• Coordinates with cross-functional team members on serious adverse event reconciliation.
• Provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required.
• May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities.
• Other duties as assigned.

Key Qualifications:

• Bachelor’s degree in a scientific subject area preferred
• Minimum 8 years of clinical data management experience in biotechnology or pharmaceutical industry
• Minimum 6 years of Electronic Data Capture (EDC) experience; IXRS development preferred  
• Proficient computer skills, including Microsoft Office applications
• Must have strong knowledge of Data Management processes and systems
• Solid understanding of clinical drug development processes required
• Must have demonstrated problem solving abilities in a team environment and strong organizational skills and the ability to work in a fast-paced environment
• Excellent written and verbal communication skills are required
• Experience and understanding of ICH, GCP and CDASH/CDISC are required
• Experience with Medidata Rave preferred
• Familiar with MedDRA and WHODrug coding
• Experience participating in regulatory submissions and inspections a plus
• Willing to travel on occasion
• Residence in the bay area preferred

Annexon’s Associate Director/Sr. Clinical Data Manager will be required to be fully vaccinated against the Covid-19 virus.  An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine.  You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.