Clinical Process Excellence Manager - Contract - Cambridge, MA
Do you have the vision and drive to transform clinical operations into models of excellence in a fast-paced pharma environment?
Proclinical is seeking a Clinical Operations Process Specialist to support the development and implementation of global standards, processes, and tools within clinical operations.
Primary Responsibilities:
This role involves cross-functional collaboration to enhance consistency, alignment, and efficiency in clinical study management. You will also contribute to training, process improvement initiatives, and governance activities, ensuring best practices are upheld across the organization.
Skills & Requirements:
- Expertise in end-to-end clinical trial processes, with experience in one or more key functions such as clinical research, clinical operations, data management, biostatistics, or project management.
- Strong leadership, collaboration, and change management skills in a matrix environment.
- Experience in clinical trial process design, harmonization, optimization, and training implementation.
- In-depth knowledge of GCP, FDA regulations, and other global regulatory requirements.
- Proficiency in problem-solving and working autonomously.
- Exposure to clinical trial conduct across multiple phases of development and therapeutic areas, including oncology and rare diseases.
- Bachelor's degree in a scientific discipline preferred.
- PMP certification is desirable but not required.
- Familiarity with training, process improvement, and project management
The Clinical Process Excellence Manager's responsibilities will be:
- Draft, develop, and create governance processes and guidance documents to improve consistency within Clinical Operations and Clinical Trial Teams (CTTs).
- Assist in developing and implementing tools, guidelines, and training for study-related processes, including presenting at team meetings and cross-functional forums.
- Manage onboarding and offboarding tools for clinical operations team members.
- Lead quarterly updates of Key Performance Indicators (KPIs), including template adjustments, trend monitoring, and reporting to the Clinical Quality Council.
- Oversee the Clinical Operations Tool Kit, reviewing submissions and maintaining regular updates of documents.
- Act as a central contact for audit processes, ensuring Clinical Operations Leadership is informed of upcoming schedules and supporting quality team efforts.
- Serve as a subject matter expert (SME) for initiatives, ensuring consistent implementation of best practices across studies.
- Independently manage assigned projects, including performance metric investigations and data analysis.
- Address gaps or inconsistencies in study management by facilitating alignment and decision-making with key stakeholders.
- Conduct post-study assessments to identify areas for improvement and lessons learned.
- Track progress on departmental initiatives and report to leadership, potentially serving as a project lead.
- Collaborate cross-functionally to review standard procedures and contribute to risk management activities.
- Support organizational training activities, including conference tracking and cross-departmental learning opportunities.
- Contribute to integration activities across the portfolio.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
.png)
