- Develop QM Plans for assigned projects and process portfolio reviews adhering to QM SOPs, associated documents and work instructions.
- Review the Clinical Data Management process portfolio on a periodic basis to confirm Quality activities are being adhered to.
- Review clinical trial data in accordance with QM Plans and applicable standardized QM processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
- Review queries and query resolution to identify erroneous or incomplete resolution of queries and/or inefficiencies.
- Develop and provide to Clinical Data Management reports on QM reviews identifying issues and supporting documentation, as well as any other quality issues or trends.
- Assist Data Management with development and implementation of action plans to address clinical database quality concerns.
- Provide feedback regarding assigned studies based on quality metrics to Project Management and Data Management.
- Attend project meetings as directed providing information to the team on quality trends or concerns.
- Initiate and maintain a QM project file for Data Management portfolio reviews and assigned studies.
- Assist in the development and maintenance of QM databases used to track study information, project and quality metrics.
- Generate and publish study specific quality metric reports as needed and department quality metrics reports.
- Perform aggregate review of clinical data by patient, site, and/or project to identify quality trends or concerns and/or data inconsistencies that require further investigation.
- As directed, participate in client audits providing information regarding the QM Program and/or providing appropriate documentation and details of quality reviews for assigned projects.
- Train project staff on project-specific, global, standardized QM processes.
- Train QM personnel on QM SOP and processes.
- Train assigned quality reviewers from departments other than QM for project specific quality reviewer responsibilities.
- Develop QM training presentations as assigned by management.
- Participate in department team meetings.
- Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
- Review literature and research technologies/procedures for improving global QM practices.
- Maintain QM competencies via participation in internal and external training seminars.
- Accountable for the development and maintenance of QM SOPs.
- Interact and collaborate with Data Management on the development of the clinical data model and/or database design to reduce the potential for database errors.
- Participate in client capability audit providing information regarding the QM Program as assigned by management.
- Potentially assist Data Management with proposal development, identifying appropriate costs/hours for QM responsibilities.
- Lead or assist with special projects as designated.
- Perform other duties as assigned by management.

- University/college degree (life 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).
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- In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year’s clinical data management experience in addition to the four (4) years relevant work experience in data management will be considered.

- Broad knowledge of drug development process.
- Understanding of global clinical development budgets and relationship to productivity targets.
- Knowledge of effective clinical data and QM practices.
- Cursory knowledge of time and cost estimate development and pricing strategies.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

- Minimum four (4) years relevant work experience with increasing responsibility in data or QM with knowledge of two (2) or more therapeutic areas.
- Demonstrated time management skills and ability to adhere to project productivity metrics and timelines.
- Demonstrated ability to work in a team environment and collaborate with peers.
- Demonstrated interpersonal skills.
- Excellent oral and written communication skills and demonstrated presentation skills.
- Knowledge of clinical trial process and data management, clinical operations, biometrics, QM, and systems applications to support operations.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
- Ability to confront constructively.
- Ability to manage multiple tasks and deadlines.
 
Potential ability to lead by example QM staff