Clinical Capabilities Associate

CLINICAL CAPABILITIES ASSOCIATESUMMIT, NJPosition will be remote until COVID restrictions are lifted.Project Description: The Clinical Center of Excellence department serves all of Clinical Research and Development across all Therapeutic areas with the objective to enhance our clinical capabilities within Clinical Development and Clinical Science organization and optimize our ways of operating with a focus on Innovation, Consistency and Quality across the enterprise. The CCoE serves as the operating bridge between the multiple Therapeutic Areas in both late development and early development striving to build a culture of excellence. The Clinical Capabilities Associate (CCA) will report into the Clinical Capability Lead (CCL).The Clinical Capabilities Associate (CCA) provides clinical and scientific support to the cross therapeutic area Clinical Development Organization with processes, systems and tools utilized in clinical trials. The CCA supports the CCL (clinical development lead) and may serve as the primary contact and advisor for Clinical capabilities within the Clinical Development organization. This role works closely with cross-functional partners, including Vendors and CROs, to ensure continuous improvement of processes and highest quality standards.The CCA will support the CCoE community of practice focused on enhancing clinical development innovation, execution, and delivery to promote a culture of continuous improvement and operational excellence.

• Support the review of procedural documents (SOPs, WIs, Job Aids) utilized by the clinical development organization and ensure alignment with the clinical leadership team.
• May serve as the process lead and or SME for clinical owned processes (e.g. Clinical Protocol, DMC, SSC, Protocol Deviations, safety narrative review etc)
• Support assigned projects with supervision by manager
• Represent Clinical during inspections and audits, and with responses and CAPA resolution for clinical development related findings.
• Determine root cause and corrective actions for platforms and systems that affect Clinical processes and efficiencies (e.g., protocol deviation process, CTMS); lead implementation efforts.
• Lead work streams for a large global Google Cloud Platform Quality Management Systems (QMS) Optimization project as it relates to clinical processes
• Support the maintenance of the clinical scientist/clinical trial physician onboarding program for new employees.
• Support the CCoE learning sessions and trainings to the clinical development organization in partnership with R&D Learning.
• Support coordination and agenda management of CCoE leadership meetings.
• Attend and lead team meetings as needed for assigned projects
• Interface with clinical and other functions for scientific and functional guidance
• Identify & escalate current/active issues to manager
• Enact best practices with instruction
• Contribute to CCoE and cross functional continuous improvement initiatives
• Actively seek and receive coaching/mentoring
• Provide regular and timely updates to manager

• Degree in Life Sciences (pending degree/graduation date may be acceptable)
• >2 years of experience in clinical science, clinical research, or equivalent
• Entry level position with expectation of >2 years of experience in CR&D roles/responsibilities or equivalent
• Awareness of Google Cloud Platform/ICH, drug development process, study design, statistics
• Excellent verbal, written, communication, and interpersonal skills
• Detail-oriented
• Entry level knowledge of clinical development roles and responsibilities
• Entry level Experience in SOP writing and process development
• Demonstrate critical thinking & problem-solving skills
• Exhibit Commitment to Quality
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Skilled in Microsoft Word/Excel/PowerPoint/SharePoint
• Ability to quickly learn clinical research systems