Manager, Clinical Processes and Systems Position Description
- The Manager, Clinical Processes and Systems provides project-related assistance to the clinical development and clinical operations teams. This includes, but may not be limited to, facilitating the development of/updates to SOPs and related documents; facilitating the review of clinical trial protocols; coordinating clinical trial disclosures and providing support for clinical application software implementation projects.
- The incumbent works cross-functionally with internal departments and external resources on Clinical Development and Clinical Operations-related projects.
- The Manager, Clinical Processes and Systems supports adherence to relevant regulatory requirements, company Standard Operating Procedures (SOPs), policies and practices.
- This is a long-term contract position
- Collaborates with clinical development, clinical operations and other functional key stakeholders to facilitate the development/update, review, approval and implementation of SOPs, Work Instructions, Job Aids, Business Process Flows or other similar documents.
- Provides support to project teams engaged in the customization and implementation of clinical application software (e.g. Clinical Trial Management System (CTMS), eTMF, etc.). This includes, but may not be limited to, data collection, data entry and testing.
- Coordinates the review of synopses, protocols, and amendments with the Protocol Review Committee.
- Coordinates activities for clinical trial disclosure with internal and external stakeholders.
- Acts as a point of contact for emergency INDs, clinical supply requests, and global DMD (Duchenne Muscular Dystrophy) genetic testing initiative.
- Performs other tasks and assignments as needed and specified by management.
- Bachelor's degree and a minimum of 4-5 years of relevant Clinical Development/Clinical Operations support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience.
- Demonstrated and applied knowledge of applicable clinical research processes and regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines.
- Experience facilitating the development, including authoring of SOPs and related documents.
- Experience with CTMS, eTMF, and other clinical applications either as an end-user or in system support capacity.
- Excellent verbal and written communication skills
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Proficiency with Microsoft Office Suite.
- Experience with clinical trial conduct/management, Trial Master Files, CTMS and other clinical systems.
- Knowledge of Visio, SharePoint, and electronic document management systems.
- Familiarity with clinical trial disclosures (i.e., CT.gov).
- GCP Audits / Inspections, Effectiveness Checks, and CAPAs.
- Computer System Validation and 21 CFR Part 11, Project Management, and Business Process Management.
- Medical, Dental, and Vision Insurance
- 401K Plan
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.