ERT is currently searching for a Director, Clinical Data Management based in our Boston, MA office. This exciting opportunity will play a critical role in developing and implementing departmental strategies and ensure high customer satisfaction with the data product provided by ERT to our client groups. In this role you will be responsible for:
- Monitor the productivity and quality of the Clinical Data Management team.
- Develop methods to track and report key performance indicators such as team productivity, successful data delivery, Query/DCR metrics, and on time delivery of services.
- Working with senior DM team members, perform resource planning to ensure appropriate staffing levels for assignment of new studies to the Clinical Data Management team. Develop strategies for study assignment that maximize staff capabilities while providing opportunity for the Data Management team to grow and learn new skills.
- Advise, cooperate and communicate with Project Management, Study Design, Programming and clients to resolve study issues.
- Primary Clinical Data Management contact for client issues and/or escalations.
- Strategize with internal teams on best resolution to customer concerns.
- Direct teams in resolving data-related customer issues.
- Ensure lessons learned are incorporated into standard processes to drive continual improvement.
- Establish the department vision and goals and provide routine communications to staff regarding corporate and department direction, vision and goals.
- Develop, review and revise Standard Operating Procedures, Standard Work Instructions, Job Descriptions, and Departmental Training as needed to ensure adherence to GCPs and best practices.
- Lead or participate in requirements gathering and bug resolution efforts for all systems affecting the global Clinical Data Management team.
- Manage the global Clinical Data Management and review/approve contract and work orders to ensure adherence to departmental functionality and procedures.
OTHER DUTIES AND RESPONSIBILITIES:
- Assist team in performing CDM-related study tasks as needed to achieve timelines.
- Promote inter-departmental collaboration to create a positive team environment, effective communications, and efficient use of resources to meet contract deadlines.
- Routine travel between ERT offices domestically and internationally.
- Participate in Global Management Team meetings and budget planning meetings.
- Bachelor Degree or equivalent required.
- Minimum of ten year’s experience in pharmaceutical field (or related industry experience), with a concentration on Clinical Data Management or Project Management.
- Minimum of six years Management/Supervisory experience essential; at least three years at a senior level.
- Demonstrated leadership skills and ability to recognize and hire outstanding talent.
- Experience with different methods and formats of delivering data to pharmaceutical industry clients. CDISC/SDTM experience required.
- Intimate knowledge FDA, ICH and EMA guidelines and positions related to data quality, site archives, and GCPs.