Senior Data Manager, Clinical Trials

Scientific Search
Oct 13, 2016
Nov 10, 2016
Employer Type
Direct Employer
Employment Type
Full Time
Job Description:

SENIOR DATA MANAGER Position Overview: With limited support from reporting manager, lead and provide oversight of the delivery of Company data management services to companies conducting clinical trials. To mentor and train new or existing staff. Responsible for independently executing and overseeing data management processes of new clinical trials during start-up phase and managing the data during the study maintenance through close-out phase in line with Company SOPs and best practices, reporting and escalating to management staff as appropriate. Responsible for identifying and/or leading process improvement initiatives, such as new systems and services while thoroughly understanding internal processes and customer needs. May also include acting as a Subject Matter Expert (SME) for a specific area within the Data Management department. May also include acting as Data Management Team Lead with direct supervision of Data Management staff. Essential Job Functions: ?? Provide oversight of data management activities for a portfolio of studies ?? Oversee set-up of software, database and study specific data management processes for clinical trials o Thorough understanding and review of clinical trial protocols o Set-up of data management tracking tools o Manage custom software build and database set-up process o Write and review supporting documentation for data management including Data Quality Monitoring Plans and Data Management Plans o Review and understand sponsor custom file format specifications and liaise with programmers as needed to determine feasibility and timelines o Thorough understanding of project scope of services related to data deliverables ?? Complete data management services of a portfolio of studies, executing against project plans and scope of services o Monitoring of study data in Company data management system for quality (integrity and completion) and resolution of data discrepancies o Managing quality control and delivery of data transfers to customers o Liaise with Company Scientific and Statistical Analysis team as needed to coordinate custom programming of data extracts and communication with sponsors regarding statistical analyses o Regular review of study timelines and data deliverables o Rigorously file all study documents and e-mail correspondence o Support client information and data reporting needs: impeccable communication and regular external and internal reporting on project progress, address and resolve all issues, anticipate issues, work internally to develop resolutions that provide client satisfaction and meet Company business interests o Manage site communications relating to data monitoring and data-related support issues o Manage external and internal communications about data management timelines o Prepare for client audits: ensure all study data-related information and filing is up to date and review all key study information in preparation for interactions with auditors o Regular reviews of study timelines, tracking of all internal work and re-work, and coordination with project managers to ensure all data management activities are adequately supported financially by study budgets ?? Identify and lead one or more of Company continuous process improvement initiatives by seeking to understand client needs and engaging Company staff across the company ?? Train and mentor new members of staff, including planning and execution of full induction schedule, and delegation and supervision of tasks ?? If acting as SME, serve as the main point of contact for issues related to the area of expertise including but not limited to managing all associated materials, training, and process improvements and liaising with other departments as necessary ?? If acting as Team Lead; o Supervise and develop reporting Data Coordinators, Associate Data Managers and Data Managers. Appropriately challenge, guide and provide growth opportunities o Work with reporting staff to establish quarterly goals and perform performance reviews o For junior staff, delegate tasks and bundles of tasks while retaining control over the quality of the work and the identification and resolution of issues o Provide guidance for Company's process improvement initiatives directly related to data management services and/or deliverables o Ensure overall compliance and adherence to Company internal procedures and study specific scope of services for studies managed by reporting staff o Oversee the team's portfolio of studies and regularly report status updates and escalate issues to Data Management Director o Work with Data Management Director regarding resource planning and hiring of new staff o Provide back-up support for department manager as appropriate Requirements: ?? Bachelor's degree in a scientific or a technical discipline (psychology, nursing, biology, sociology, computer science or engineering) or demonstrated professional experience, preferably with data, software or other technical discipline ?? Minimum 5 years related work experience with a minimum of 3 years clinical trial experience ?? Prior supervisory experience desired Other Skills/Abilities: ?? People skills: within the team, and with customers and third party providers, strong desire to learn, to seek feedback on performance and to learn quickly ?? Communication skills: both written and oral, and particularly understanding of when to follow-up with internal and external team members and to escalate to senior staff ?? Work skills: eye for detail, problem solving, compulsion to check and double-check work product, ability to learn quickly and work fast, impeccable record keeping and compliance to procedures, high level of computer literacy ?? Good organizational skills: handling multiple tasks, establishing and managing competing priorities, ability to work independently and to be proactive ?? Strategic, creative thinking and planning skills: anticipating resource requirements, identifying opportunities for improvements and customer added value and leading improvement initiatives ?? Aptitude for understanding and leading one's work from Industry, Regulatory and Quality, Commercial and Financial concepts

Company Description:

Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.