What are the responsibilities and job description for the Clinical Data Manager position at Proclinical?
Clinical Data Manager - Contract - California US
Proclinical are partnered with a truly exciting Mid-Sized Biotech to find an experienced Clinical Data Manager as they are placing extensive investment into the growth of their Data Management function.
Primary Responsibilities :
The business are leading groundbreaking research within the Immunology space and are now at a key point in their history with several studies approaching submission and the early phase pipeline continuously growing.
Skills & Requirements :
Bachelor's degree or an equivalent within a scientific / pharmaceutical / data focused area
Minimum of 4 years of relevant CDM experience
Experienced in a study leadership position
Excellent communication skills
The Clinical Data Manager's responsibilities will be :
Act as Data Management Lead on assigned studies by ensuring all deliverables are produced according to quality standards, regulatory requirements and ensures adherence to project timelines and budget from study start up through database lock / archive.
Ensure data management databases are developed, validated, and meet company requirements.
Oversees interactions / deliverables with 3rd party vendors and CROs on collection, transfer, reconciliation of study specific data.
Responsible for the oversight of data review, reconciliation, and data cleaning activities for all assigned studies.
Reviews and / or provide input on protocols, standard operating procedures (SOP), work instructions (WI) for data management department
Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness.
Performs other related duties as required and assigned.
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