Senior Manager, Clinical Data Management

Job Title: Senior Manager, Clinical Data Management
Job ID#: CDM0514
Employer: Q-square Business Intelligence, Corp.
Worksite: 310 Flagg Hill Road, Boxborough, MA 01719

Responsibilities:
Accountable for all protocol level development, maintenance and finalize tasks and activities performed by CDM; Responsible to design, create, validate, review, maintain and archive data management documentations, including but not limited to: Data Management Plan, Database, CRF, Time & Events Schedules, CRF Completion Guidelines, Data Validation Plan, Data Validation Report, Coding, Data Transfer, Database Lock and Data Management Report; EDC and IWRS system setup, maintain, execute the user acceptance testing and provide
technical support to the users; Collect the clinical data by EDC system or double data entry for paper study; Use available data management tools to implement the data review plan and perform data cleaning, generate query, post query and track query; Per protocol, identify protocol deviations and send them to the responsible party; Generate clinical data management reports periodically, including the subject enrollment status, query status; Implement SAE reconciliation, medical coding, data transfer, data quality control following SOPs; This position will supervise Clinical Data Managers

Requirements:
Bachelors Degree in Data Science, Mathematics, or related fields;
5 years of experience as Clinical Data Management related positions;
Business meeting with existing and new prospective clients in U.S., Each trip lasts no more than 5 business days, The expected frequency is twice per year;
Telecommuting within the U.S. is allowed.

Apply, mail CV with Job ID# to Jian Guo, 310 Flagg Hill Road, Boxborough, MA 01719