Clinical Data Manager Jobs
Old Lyme, CT
Job Summary
Serves as the primary Kendle CDM contact with Sponsors and represents CDM on project teams. Responsible for project timelines, deliverables, financial results, reporting and overall quality. Primary responsibility for Level 4 Balanced Score Card (Biometrics stand-alone). Responsible for the creation and maintenance of CDM project budgets and essential CDM documents for assigned projects. Approves the building, testing and validation of clinical databases. Coordinates the receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data received from specialty groups (e.g., lab data, e-diary data) utilized on projects. May function as a Biometrics Project Leader responsible for CDM, Programming and Statistic services. May participate in the training of CDM associates. Supports new business development duties.
Core Responsibilities
Finance
Manages the CDM budget for assigned projects (full-service). May be responsible for managing Biometrics budget for Biometrics stand-alone projects
Identifies CDM activities outside the scope of contracted work, prepares cost analysis documentation and follows scope issues through to resolution
Operations
Directs the activities of CDM team members to complete project deliverables on schedule and according to quality standards, requirements and project budget from study start-up through archival
Develops and modifies CDM Documents (Data Management Plan, Data Validation Plan) including data cleaning guidelines, conventions, data workflow and other processes which will be followed to meet sponsor contracted deliverables
Coordinates CRF design in accordance with the protocol and established standards if applicable.
Approves the building, testing and validation of the clinical database
May perform database testing
Coordinates receipt and handling of data received from external sources (e.g. central laboratory, ECG, sponsor coding dictionaries) and directs reconciliation where applicable
Maintains CDM project documentation in an audit-ready manner
Ensures projects are conducted in compliance with operating procedures and good clinical practices.
Represents Kendle data management on project teams. Manages scheduling and time constraints across multiple projects and multiple locations
Maintains positive working relationship with internal customers and Sponsor
Keeps Sponsor and team members aware of project issues
Tracks timelines in relation to work completed and keeps CDM management, sponsor and the project team appraised of progress towards milestones
Maintains a consistent, manageable workflow for CDM project team by monitoring enrolment information and communicating with project team to actively influence data collection
Recommends alternative work processes to improve the quality or speed of customer deliverables and responds to sponsor/team questions on CDM process, timelines and data quality
Conducts an analysis after study completion to determine positive and negative factors affecting the project and provides this information along with study metrics to CDM management
May function as a Kendle Biometrics Project Leader, coordinating the activities of programming and statistical associates and ensuring that databases are validated and ready for transfer and/or analyses
May participate in internal CDM projects such as developing SOPs, implementing new technologies or processes, assisting with user testing, establishing CDM standards or providing input into process development, build new tools or templates
May coordinate programs or projects across multiple Kendle offices
Sales & Marketing
Supports the preparation of fee estimates for project proposals, CIS, and contract modifications
Participates at bid defence meetings and sponsor presentations
Personnel / Staffing
Accurately estimates hours needed to complete CDM activities and proactively keeps Project Leader and CDM management informed of resource needs and under/over utilization
Provides or arranges for project specific training for CDM team members
Monitors quality of work performed by CDM project team; coaches staff where necessary
Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
Contributes to performance reviews of project team members
Supports Biometrics goals by sharing project team resources globally to meet deadlines when possible, providing constructive input into department decisions and sharing knowledge and best practices with other CDM personnel
May participate in recruiting efforts
Skills & Attributes
The candidate/incumbent is preferred to have a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline. Candidate/incumbent should have a minimum of 4 years experience in clinical data management and 1 year experience working in a project management role. Candidate/incumbent should be familiar with using a PC in the Windows environment. Knowledge of CDM database management systems is desirable. Knowledge of regulatory guidelines related to CDM activities is considered important. Working knowledge of English is essential.
For more information please call 800-733-1572
