Job Category: Clinical & Statistics

CLINICAL DATA MANAGER

Job Location: N/A

CLINICAL DATA MANAGER

We are looking for Clinical Data Managers with backgrounds in multiple Therapeutic Focus Areas for full time and contract positions.


RESPONSIBILITIES:

Works collaboratively with vendor Project Managers and Clinical Data Managers to assure that Data Management functions are performed in compliance with regulations and according to study protocol and the Study Data Management Manual. Works with involved parties to assure that DMM is prepared according to company SOP’s and in compliance with data standards. Coordinates, leads and performs clinical data management activities for assigned studies in accordance with SOP’s and policies and practices. Serves as primary DM contact for assigned studies, including representation on project teams and working with CRO’s performing data management tasks for assigned study. Monitors data clean-up process performed by CRO’s from study start-up through data archiving. Provides data for analysis. Coordinates activities including: medical coding; data validation checks and database snapshot. Prepares and distributes project status reports to project team and management. Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or analyses in accordance with SOP’s. Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF. Responsible for the initiation and approval of the building, testing and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Contributes to upkeep DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization. Works with study team and coordinates all data management functions. Manages coordination of CRO data manager and project team to ensure that tasks are performed according to policies and procedures. Adheres to procedures surrounding retention of data, records, and information for clinical studies.


REQUIREMENTS:

Bachelor degree in Mathematics, Science or a related field, along with 3+ years of clinical data management experience in biotechnology, pharmaceutical or health related industry. Self-directed and comfortable working in teams, with the ability to work and operate independently within a tight deadline environment is a must. Familiarity with all applicable regulations: CFR, GCP, and ICH. Strong analytical and project management skills. Strong written and oral communication skills required. Proficient in: EDC applications, Microsoft Office applications, CDMS required. Experience with JMP and SAS a plus.


Please contact Manja Molan at mmolan@clarkdavis.com

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