Data Manager

Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code to create Precision Biologics, this includes next generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as novel cytokines to modulate the immune system and long acting therapeutic peptides for metabolic and cardiovascular disease, all designed to have improved pharmacologic properties and novel biological activity.

Responsibilities:

• Work with CROs to support data processing, standardization, review, transfer and integration for statistical analysis, study reports, manuscripts and presentations.
• Support eCRF creation.
• Ensure data handling procedures are compliant with regulatory guidelines, adherence to standards, collection of high quality data, accurate reporting and timely completion of clinical trials.
• Responsible for reviewing, importing and implementing ADaM, SDTM, and RAVE data into clinical workflows.
• Support system validation and HA inspections
• Provides insights of data management across the portfolio.

Requirements:

• 5-10 years of hands-on pharma industry data management experience in oncology area
• Medidata platform implementation.
• CRO and vendor management experience

To be considered for this opportunity, please submit your resume/CV referencing the position code.. Applicants whose qualifications and experiences most closely match the requirements will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensations & benefits. EOE.