Job Listing: Senior Clinical Data Manager

Our Client a mid sized Pharmaceutical company in Cambridge is seeking a highly motivated individual to join our Clinical Data Management team.

Job Description
-The Senior Clinical Data Manager will perform and/or oversee data management study requirement specifications creation, in-stream data management cleaning activities, vendor management, and study closeout procedures.
-The Senior Clinical Data Manager will participate in the definition and evolution of departmental processes and standards development and will work closely with Biometrics and Clinical colleagues to ensure continuous alignment of study data management objectives and expectations.

Responsibilities
-Perform, or supervise the performance of, the following activities:
Participate in protocol development
-Create the study Data Handling Plan
-Create & test data validation specifications
-Liaise with external vendors to define/review trial requirements
-Participate in defining the database management system trial reporting requirements
-Participate in CRF user acceptance and provide final build approval
-Creation of eCRF guidelines and end user documentation
-Participate in site personnel training
-Oversee electronically generated edit checks
-Perform manual review as outlined in the data handling plan
-Actively manage vendor assigned tasks
-Report status for DM activities to intra-/inter-departmental colleagues and senior management
-Maintain ownership for all aspects of data cleaning and delivery
-Actively manage trial progress against data management milestones
-Manage in-stream database and eCRF changes
-Proactive identification, management, and escalation of issues
-Ownership/maintenance of the data management study files
-Perform, or oversee, medical coding activities
-Manage all data transfer events
-Approve and provision final study deliverables
-Ensure all required documentation is completed and appropriately archived
-Participate in the development of procedural documentation, including SOPs, Guidance Documents, and supporting document templates

Requirements:

-Minimum four years of clinical trials data management experience
-Minimum of B.S. degree or equivalent in scientific or medical field
-Prior trial responsibility for the entire data management life cycle, from requirements definition through database lock
-Experience with oncology trials desirable
-Familiarity with creation and/or application of data standards
-Experience with vendor management (i.e., Labs, ECG, Imaging data)
-Experience with electronic data management systems
-Basic working knowledge of SAS desirable
-Ability to work effectively with cross-functional project teams
-Knowledge of regulatory requirements for data management activities

Required Skills for Senior Clinical Data Manager Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.