Clinical Data Manager I
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Clinical Data Manager 1
Remote, Home-Based in the USA or Canada
The selected candidate will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Additional responsibilities include:
– Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate i n the development of the clinical data model and/or database design and annotate the CRF (eCFR) according to these specifications I monitoring conventions.+ Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical suppo1t, drug safety, etc.) to suppo1t the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
– Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
– Review data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion
– Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
– Advanced planning and risk management for projects (issue escalation, resource management).
– Assist with goal creation and performance review assessment for data review project staff.
– Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.+ Support achievement of project revenue and operating margin for data management activities to agreed target
– Identify areas for process and efficiency improvement and implement solutions on assigned projects.
– Maintain technical data management competencies via pa1ticipation in internal and external training seminars.
– Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
– Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as
– Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
– Perform other duties as assigned by management.
– Review literature and research technologies/procedures for improving global data management practices.
Education/Qualifications
– University/college degree (l ife science, pharmacy or related subject preferred), or certification
– in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
– Additional relevant work experience will be considered in lieu of formal qualifications.
– Broad knowledge of drug development processes.
– Understanding of global clinical development budgets and relationship to productivity targets.
– Knowledge of effective clinical data management practices.
– Knowledge of time and cost estimate development and pricing strategies.
– Thorough knowledge of TCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing. Experience
– Minimum five (5) years relevant work experience in data management with approximately one ( 1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
– Demonstrated skill for technical management of staff exceeding 5 employees.
– Financial management of gross revenues in excess of $250K per year.
– Excellent oral and written communication and presentation skills.
– In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
– Working knowledge of the relationshi p and regulatory obligation of the CRO industry with pharmaceutical I biotechnological companies.
– Ability to lead by example teams on project strategies and achievement of depa11ment goals, objectives, and initiatives and to encourage team members to seek solutions.
– Demonstrated managerial and interpersonal skills
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
