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Principal Clinical Data Manager-biotech/pharma (oncology)

THIS IS A REGULAR FULL TIME ROLE THAT INCLUDES FULL BENEFITS PACKAGE, BONUS POTENTIAL AND POSSIBLE STOCK OPTION

THIS ROLE IN ONSITE AT THE CLIENT OFFICES IN EITHER WEST LA OR SOUTH SF

NO REMOTE OR TELECOMMUTE OPTION FOR THIS ROLE

 

Primary Objective of Position

 

Principal Clinical Data Manager, Clinical Data Management, is  responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off ; Reviews and approves CRO generated Data Management documents,  coordinates database live and close out activities with the CRO,  provides guidance to CRO to manage query flow and implements quality control plan.  The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed;   may participate in vendor qualification and selection as appropriate, and participates in monitoring vendor performance

 

Major Duties/Responsibilities

 

Reviews listings to identify data discrepancies and tracks resolutions

 

Works with Study team to design mock CRFs based on the protocol

 

Leads database design, implementation and testing activities

 

Supervises all Data Management deliverables and associated timelines with the CRO to ensure a quality database lock

 

Co-ordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety and other departments, as needed, to resolve data issues

 

Skills & Abilities

 

Excellent organizational skills and ability to prioritize tasks

 

Must be able to work under tight timelines

 

Possess excellent communication skills

 

Anticipates change and reacts quickly and intelligently to accommodate business needs.

 

Physical Demands

 

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

 

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.   May involve travel up to 10%

 

Education & Professional Experience

 

Required:

 

Bachelor’s Degree in a biological sciences or other medically related areas

 

Minimum of 7 years of data management experience in the biotechnology/pharmaceutical industry

 

Familiarity with data management software (e.g. Medidata, Oracle Clinical)

 

Working knowledge of coding dictionaries – MeDDRA and WHODRUG

 

Preferred:

Knowledge of Oncology clinical trials

 

Nursing background

 

Vendor management experience

 

Familiarity with SAS

 

 

 

 

Filed Under: CDM (Clinical Data Manager)

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