Associate Clinical Data Manager

San Jose, United StatesRemote

Responsibilities

Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.
Develop and maintain client relationships and review client satisfaction surveys.
Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed.
Maintain accurate records of all work undertaken.
Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate.
Utilize local laboratory systems and batch data load facilities where appropriate.
Address client comments with the study team.
Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines.

Ability to organize and effectively prioritize workload and deliverables.
Qualifications: University degree in Life Sciences, Health Sciences, Information Technology, or a related field. Equivalent
experience in clinical research or data management may be considered in lieu of a formal degree. Fluent in English, both written and verbal. Knowledge of science or a scientific background.
experience in clinical data management or related roles.
Understanding of GCP, ICH guidelines, and clinical trial processes.
Knowledge of Data Management, Clinical Operations, Biometrics, and system applications to support operations.
Familiarity with Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault)
Experience working in cross-functional teams and supporting global stakeholders.
Strong organizational and time management skills with the ability to meet project productivity metrics and timelines.
Knowledge of medical terminology.