To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02588

About our client Our client is a rapidly growing global CRO headquartered on the east coast. The company has managed close to 150 protocols, boasts a deep network of over 3000 sites and has developed unparalleled expertise in cardiology and device studies. With strong financials, an experienced management team and loyal customer base, this is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Data Manager Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate the review of clinical trial data 2) Identify erroneous, missing, incomplete or implausible data and write queries 3) Develop data validation guidelines, Clinical Report Form (CRF) completion guidelines and override guidelines for each clinical study 4) Represent Data Management at Project Team meetings and provide updates to the project team on status of CDM tasks 5) Communicate with Project Manager and Project Coordinator regarding project team and/or client issues 6) Supervise, coach and develop staff 7) Ensure that required (current) training for directly supervised staff members is identified and provided within a reasonable timeframe 8) Assign tasks to data reviewers 9) Communicate with client regarding CRF design issues 10) Design CRFs and coordinate CRF review by project team 11) Oversee coding of adverse events and medications 12) Ensure timely and appropriate resolution of clinical team and/or client issues 13) Coordinate the printing and shipping of CRFs 14) Ensure that all external data is imported into the database 15) Coordinate with IT to ensure proper submission and incorporation of central or core lab data 16) Ensure adherence to all timelines associated with data management 17) Coordinate with Project Coordinator to ensure timely site submission of CRFs and queries 18) Ensure that the data management needs of project(s) are met, reporting all areas of concern to the Director of Data Management Requirements 1) Bachelor’s degree in a scientific or technical area or equivalent education and experience 2) An advanced scientific degree or clinical certification a plus 3) 3 years of clinical data management experience in a pharmaceutical company or CRO 4) Supervisory experience preferred 5) Experience in developing and leading effective presentations in public settings 6) Knowledgeable about the federal (FDA) regulations and requirements governing the conduct of drug, biologic and device studies, including GCP and ICH requirements 7) Team-building ability with the ability to work successfully in a team environment 8) Demonstrated skill in the management and resolution of data-related issues