Clinical Trial Operations Manager
6 Month Contract
Rate: up to 90/hr W2
Lead the creation, revision and maintenance of cross-functional clinical SOPs that support the development of product portfolio spanning from early development through to post marketing. Initiates and implements process maps and other documentation to ensure compliance to SOPs. Supports global inspection readiness and identifies best practices in collaboration with subject matter experts in relevant functional lines and with CRO partners. Provide support to the clinical study teams throughout their lifecycle to ensure quality in practices. Facilitates the root cause analysis of audit findings, quality issues and other non-compliance events in order to develop and implement preventative actions. Support the identification and management of risks across clinical study processes. Develop and deliver innovative training solutions and other training materials as appropriate in partnership with Clinical Training Lead.
- Develops SOPs, process maps, forms, templates, guidelines and other documentation to support the development and/or revision of clinical documentation based upon regulations, strategies, goals and standards
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to clinical processes and SOPs and proactively makes recommendations to implement as appropriate
- Collaborate with cross functional subject matter experts to design and document processes and develop documentation.
- Engage with CRO partners to ensure a seamless connection between Alexion SOPs and processes with those of our CRO partners
- Monitor the impact of any business process or regulatory changes on SOP documentation and make the appropriate recommendation
- Review SOPs on a routine basis and revises SOPs, process maps, forms, templates, guidelines and supporting documentation when appropriate
- Facilitate the root cause analysis of non-compliance issues including audit findings and quality issues and develop and implement preventative actions
- Identify and manage risks across clinical study processes.
- Serve as the subject matter expert for clinical SOPs and serve as a resource for study teams throughout their lifecycle
- Maintain repository of SOPs, process maps and related compliance documentation
- Employ change management philosophies during implementation of SOPs and support compliance documentation
- Partner with clinical training lead to develop and implement innovative SOP and compliance training programs/materials/tools.
- Support regulatory audits and inspections
- Develop and manage associated project plans
- Establish and monitor processes to maintain currency and accuracy of best practices
- Develop, track and report key performance and quality indicators
Company Description Armstrong Consulting Group helps companies in diverse industries by providing contract, contract to hire and permanent staffing solutions in all areas of Information Technology, Engineering, Pharmaceutical and Administration.
We attract, recruit and deliver the highest quality professionals best suited for organizations by fully understanding the requirements and culture of our customers. As a highly respected and professionally managed team with over 25 years experience in the staffing industry, we foster long term relationships with clients and candidates as they successfully grow their businesses and careers.