Brief summary of the role:
The Lead Clinical Data Manager is a member of the project team and is the primary data management contact with the client and clinical team who is responsible for all data management activities encompassing multiple aspects including study start-up, operations, data auditing and closeout to ensure a high quality database delivered on time.
Primary Data Management contact for the client and study team members as well as is responsible for all aspects of Data Management project start-up activities such as CRF design, database design specifications development, Data Management Plan development, Edit check specification development, and other process documents (i.e. Data Entry Guidelines or CRF Completion Guidelines) as well as creating study related documentation and listings. Collaborate with the CRF designer, Programmer to ensure the CRF is designed appropriately. Responsible for defining data review processes and defining reporting specifications to ensure data quality integrity.
Responsible for delivering quality databases to stakeholders and communicating any clarifications or details that would affect the data analysis to the project team by ensuring that Clinical Data Coordinator and Clinical Data Manager staff perform data and/or manual listing review to identify potential data discrepancies and inconsistencies for assigned projects. Identifies and shares data trends with the project team.
Reviewing and resolving all study related issues raised by study team members with consultation from the Senior Managers, when needed, to ensure all study-related tasks are completed on time and with high quality. Responsible for adhering and managing the timelines as well as budgeted hours.
Manage third party vendor transfer plans, data transfer, as well as reconciliation and troubleshooting of the vendor data. Resolve issues identified during the data review process and determine if process/plans need revision.
Responsible for process and budgetary efficiencies, communicating with cross-functional teams, overall timeline management for Data Management tasks, assist with budgeting forecasted hours and potential budget impacts, setting study metrics for indirect reports, promotes collaborative cross functional team building. Develop technical specifications for data management programming and communicate needs to information technology staff.
BA/BS degree in biological sciences or related disciplines preferred
Minimum of 5 years Data Management experience, or equivalent combination of education and experience
Working knowledge of MS Office products to support word processing, EDC application or other data collection systems, e-mail applications and spreadsheet activities
Knowledge of medical terminology, clinical data, and/or ICH/Good Clinical Data Management practices preferred;
2-3 years of Oncology experience preferred, but not required
Ability to work in a team environment and collaborate with peers;
Strong written, organizational and verbal communication skills;
Strong interpersonal skills and have a clear understanding of the escalation process;
Ability to work on a minimum of 2 projects simultaneously. A solid understanding and experience with:
CRF design and development, Database structure and design, Adverse Event and Concomitant Medication coding, and timeline and deliverable management;
Prior experience with Clinical Project Management, CRAs, biostatistics and SAS programming preferred;
Thorough and broad knowledge of data management processes, including EDC and interactive voice response system (IVRS) experience.