Senior Clinical Data Manager

San Francisco, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

Participate in clinical meetings with Sponsor and KPS personnel as required.
Take necessary actions to ensure data management deliverables are met.
Establish rules and procedures for secure and responsible data sharing with executives.
Manage data management resourcing for all clinical studies as required.
Prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
Ensure delivery of a clean and secure database.
Instruct communicate coach and mentor others on data management procedures.
Ensure compliance with EMEA FDA and ICH GCP regulations and policies.
Ensure compliance with appropriate Sponsor SOPs.

Requirements:

BS/BA or masters degree with preference in a biological analytical/data health related or computer science field.
7-10 years related experience in a pharmaceutical or CRO setting.
5 years experience in Data Management.
Knowledge of EDC solutions (Oracle Clinical Medidata RAVE Inform etc.).
Experience working on studies both insourced or outsourced to a CRO.
Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite).
Strong management and motivation skills.
Ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines.
Extensive and comprehensive knowledge of international ICH GCP guidelines.
Excellent interpersonal written and oral communication skills.

Responsibilities: Participate in clinical meetings with Sponsor and KPS personnel as required. Take necessary actions to ensure data management deliverables are met. Establish rules and procedures for secure and responsible data sharing with executives. Manage data management resourcing for all cli...