Senior Clinical Data Manager

Senior Clinical Data Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

• Perform DM activities for in-house and outsourced trials: protocol review, CRF development, database set up activities, data validation process (including manual data review of listings), SAE reconciliation, managing local laboratory and external labs and database lock

• Perform Project Management: represent DM on clinical teams, coordinate deliverables by other functions and/or CRO as necessary to achieve DM deliverables

• Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM)

• Coordinate CRO data validation activities (coordinate data transfer specs, data reconciliation, query generation and resolution)

• Participate in the development and implementation of department standards and documents, and other data management, departmental activities as needed

• Serves as Project Data Manager for large projects or multiple smaller projects

• Conducts internal and external team meetings, including monthly project review meetings, representing Clinical Data Management

• Provides professional Data Management input on International Clinical Teams (ICTs)

• Responsible for ensuring consistency of protocols, Validation and Analysis Plans (VAPs) & Project eCRFs for all trials within assigned projects

• Coordinates and conducts setup activities, such as CRF design for complex trials, database structure design, CRF annotation, project document creation and/or approval, data entry screen design and testing, validation check creation, testing and approval

• Performs data management activities for studies conducted in-house; oversee and coordinate activities of CRO handling outsourced projects (protocol review, CRF development, database set-up activities, data validation process; medical coding, SAE recon)

• Provides input, review, and maintenance of global working practices and standards

• Track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases

• Ensures appropriate Novartis tracking systems are up to date and accurate

• Serve as SME for SAE and PK reconciliation

• Leads and support clinical & non-clinical special projects. SIV & INV meeting participation for DM presentation.

Qualifications

• Bachelor degree or above in scientific or related field Minimum 5-7 years' experience in Data Management with experience in managing projects, project teams

• Experience with In-Form or other EDC software is desirable however, should have some experience in supporting Oncology studies

• Must be able to work independently

• Proficiency on all related regulations, GCP, and Good Clinical DM Practice

• Project management skills required

• Strong oral and written communication skills. - Leadership skills a must