Senior Director, Clinical Operations Process, Systems & Inspection Readiness Location Princeton, NJ
Serves as the business and process strategic leader responsible for defining and driving business processes in order to: maintain the quality and completeness of the Trial Master File System (paper or electronic) and CTMS system; assess the need for and oversee the implementation of new clinical operations business processes, SOPs and group training and to maintain existing SOPs and GCP tools in a current state; ensure that the clinical programs conducted by ACADIA are in a state of inspection readiness with high standards for quality. The candidate will be required to set strategic direction for the above, and will work collaboratively, in conjunction with the various operations teams to manage process improvement initiatives within timelines and budgets. The role will also work with Clinical Service Providers (CSPs), and other departments to create, maintain and manage quality processes, systems and data. The role will be required to recommend and implement remediations and corrective actions, when necessary to ensure the integrity of ACADIAs systems, processes and clinical documentation are maintained in accordance with corporate and regulatory directives.
- Oversee the Clinical Operations SOP/guidelines maintenance and retirement; Direct work related to new process creation, training and rollout.
- Manage processes for ensuring that clinical operations and related vendors using ACADIA processes are current with training and training documentation; may conduct training for small groups and participate in training sessions for CSPs and investigators.
- Work with IT and business process owners to ensure optimal use of systems and tools related to clinical trial tracking, eTMF and CTMS; recommends enhancements to streamline data capture and review of key information.
- Develop and lead a GCP inspection readiness program for cross-functional teams preparing for health authority submissions for marketing approval; support clinical operations to ensure inspection readiness deliverables are met within required timelines; assess and monitor KPI/KQI related to inspection readiness.
- Develop/implement and maintain inspection readiness tools, reference materials and training slides; provide lessons learned from mock and actual inspections.
- Oversee records & information management for all active clinical development projects at including the harmonization of TMF processes and contents, and other applicable records, ensuring that they are inspection ready; this may include participating in, or support of, TMF internal or external health checks.
- Collaborate with Quality Assurance in inspection logistics which may include: securing supplies, organizing primary and secondary back-up contacts, retrieval/QC of documentation.
- Drive the strategic direction for implementation and maintenance of electronic Trial Master File (eTMF) system; collaborate with IT and business owners for any configuration enhancements, and change controls.
- Identify document management gaps / issues and work with the clinical teams to develop strategies that improve the processes while mitigating risks and resolving issues.
- Support clinical teams to assess document management-related findings for process improvement opportunities (can be inspection related or in general).
- Develop strategies to ensure adequate collection and communication of identified issues within the Clinical Operations group and affected work groups; work to prioritize and implement process improvements, where required, and demonstrate a collaborative approach to problem solving.
- Manage, develop and support staff; plan, assign and direct work; address issues and provide solutions.
- Support the VP of Clinical Operations in the management of inspection readiness activities, and lead, direct, or conduct other projects/tasks as requested.
Bachelors Degree in science with preference in a healthcare field.. Advanced degree preferred. Minimum of 10 years of experience in the pharmaceutical industry, with at least 8 in compliance, quality, training or clinical position. Health Authority inspection experience is required. Six Sigma credentials and experience with CTMS are strongly desired.
- Good understanding of GCP and ICH guidelines; thorough understanding of the drug development process.
- Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment with demonstrated ability to provide solutions.
- Strong knowledge and experience with the DIA Reference model for Trial Master Files; a subject matter expert to assist and support project teams on good documentation and filing practices.
- Demonstrated problem-solving abilities, strong attention to detail and inspire and maintain a can-do attitude.
- Ability to work in a fast-paced environment and maintain focus, commitment and balancing of priorities.
- Ability to assume accountability for completing multiple competing tasks in a timely manner.
- Ability to develop partnerships within own team and across functions in within the organization and with clinical service providers.
- Ability to anticipate difficulties and proactively develop solutions to mitigate risks.
- Customer focus and uses excellent interpersonal, communication and facilitation skills.
- Ability to work with different functional areas within the company and accomplish tasks in a matrix environment.
- Demonstrated success in facilitating, communicating and implementing improvement initiatives is a must. Communicating and balancing the approach to issue management and mitigation planning.
- Working knowledge of GCP and demonstrated skill in effective written and oral communication, collaboration/negotiation skills and proven record of being an effective team player are required.
- Strong technical skills with MS Office, Adobe Acrobat, Excel, and eTMF filing systems required (e.g., Veeva Vault).
Associated topics: administrative assistant, administrative officer, administrative staff, associate, beverage, chief operations officer, document, facilities, front desk, front office