Associate Director of Regulatory DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an ...
Associate Director of Regulatory DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an ...
D., PharmD) are preferred. 9+ years in clinical research or relevant scientific, industry, therapeutic or geographic experience Relevant industry experience includes experience in planning and ...
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Clinical Research Rater Remote information
What is a clinical research rater?
What are the key skills and qualifications needed to thrive as a clinical research rater?
What are some typical challenges faced by remote clinical research raters, and how can they be addressed?
What is the difference between Clinical Research Rater Remote vs Clinical Data Entry Specialist?
| Aspect | Clinical Research Rater Remote | Clinical Data Entry Specialist |
|---|---|---|
| Required credentials | High school diploma or equivalent; some roles may require clinical or research experience | High school diploma or equivalent; data entry skills preferred |
| Work environment | Remote, flexible hours, often part-time | Remote or on-site, regular hours, often full-time |
| Employer and industry usage | Pharmaceutical companies, research organizations, clinical trial sites | Healthcare providers, research organizations, hospitals |
While both roles involve working remotely in the healthcare and research industry, Clinical Research Rater Remote focuses on evaluating patient data and clinical outcomes, whereas Clinical Data Entry Specialists primarily input and manage clinical data. The roles differ in responsibilities, with the former emphasizing assessment and analysis, and the latter concentrating on data accuracy and entry.
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Full-time
Re-posted 24 days ago
Job description
DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Associate Director of Regulatory to join our team.
Duties amp; Responsibilities:
- Completes all the DMCR-Required Training
- Maintains a working knowledge of current FDA Regulations, ICH-GCP guidelines, organizational SOPs, and guidance documents
- Leads Regulatory team in establishing strategic direction and operational management of Regulatory
- Documents and Binder Management, including, process renovation, system amp;amp; technology, inspection readiness, and outsource amp; vendor governance.
- Establishes effective oversight and partnerships with internal and external stakeholders, with clearly defined metrics and performance targets and risk mitigation, where required.
- Manages staff amp;amp; responsible for functional activities โ staff resource management, hiring, performance and development management.
- Evaluate workflows and processes of Regulatory amp; Clinical Data teams; Propose amp;amp; Implement revisions to
- increase team productivity, efficiency, and effectiveness.
- Develop amp; Maintain Standard Operating Procedures for the Regulatory Team.
- Ensure amp; Monitor quality control for all team members.
- Develop amp;amp; Maintain a working knowledge of current FDA regulations, GCP/ICH Guidelines, Organizational SOPs, and Guidance Documents.
- Lead strategic projects across the organization to improve the quality of Regulatory
- Responsible for continuously improving team members amp;#39; quality through Technical Training, and Soft-skills
- training.
- Responsible for all leading, developing and coaching Regulatory team members, selecting and hiring new team members in partnership with the HR Department.
- Responsible for developing and reviewing job descriptions and explaining the new / revised duties to the team members.
- Any other duties/ tasks assigned by the manager.
Knowledge amp; Experience:
Education:
- Minimum undergraduate complete in Bachelors of Science or relevant
- Minimum 5 years of experience in the Clinical Research industry
- Minimum 2 years of management experience in any industry
- N/A
- Minimum of 5+ years of working in clinical research with specific experience in regulatory binder and documents management.
- Advanced degree or combination of bachelorโs degree in life-sciences/healthcare/pharmacy and relevant industry experience.
- Extensive knowledge of regulatory standards (ICH-E6) and industry-wide standards in regulatory binder and document management.
- Demonstrated success in planning and executing cross functional change projects, strong influencing, and presentation skills. Ability to communicate effectively at all levels.
- Minimum of 3 yearsโ experience in direct people management or matrix management of project/clinicalteams.
About DM Clinical Research
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Houston, TX, US
Year founded
2006