Senior Clinical Data Manager

March 12

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Annexon Biosciences

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Unlocking the Next Generation of Complement Therapies

Neurodegeneration • Autoimmune • Ophthalmology

51 - 200

💰 $130M Post-IPO Equity on 2022-07

Description

• The Senior Clinical Data Manager (CDM) will work collaboratively in a fast-paced, cross functional team environment. We are seeking a highly motivated individual to join our dynamic Data Management 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, CDM or Executive Director, CDM.

Requirements

• 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 • Proficient in cross collaboration with other functions such as Biostatistics, Statistical Programming, Pharmacovigilance and Clinical Operations • Excellent written and verbal communication skills are required • Experience and understanding of ICH, GCP and CDASH/CDISC are required • Experience with Medidata Rave preferred • Experience with elluminate, or comparable analytics software preferred • Familiar with MedDRA and WHODrug coding • Experience participating in regulatory submissions and inspections a plus • Willing to travel

Benefits

• Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/ • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance. • We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry. • Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.