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Key notes:

The primary focus is to ensure that clinical processes are efficient, effective, compliant, and successful metrics.Ideal if the candidate has experience writing SOP's and experience supporting QA/QA process improvement huge PLUS!This role is supporting the study teams/providing a service to these teams for clin ops. (supporting stakeholders = making their life easier / providing a service to all the study teams from a clin ops perspective).Team structure is Reporting Manager - Madhura and then (2) other team members - 1 is focused on training (Sara) the other is monitoring oversight on CRO operations (Mark).

Position Summary

The Senior Manager, Clinical Operations Business Optimization will partner with the Director, Clinical Operations Business Optimization to execute Clinical Operations strategic plans and projects to drive operational efficiencies across Clinical Operations and for business process optimization. They will support delivery of Clinical Operations strategic priorities by participating in Clinical Operations process improvement projects and supporting implementation of function-wide initiatives. In addition, they will support the Business Optimization Director with the oversight of Clinical Operations processes and training and inspection readiness activities.

Key Responsibilities

Proactively identify and address opportunities for process or business improvements including operational efficienciesSupport the execution of opportunities for the enhancement of core capabilities within Clinical OperationsSupport Clinical Operations initiatives (including lessons learned process) to develop innovative processes and technologies to advance operations.Support tracking and following up on Clinical Operations staff compliance with all applicable SOPs and organization of onboarding efforts for new Clinical Operations hires.Contribute to budget planning and management.Act as a resource for the Clinical Operations team members for processes, training, and inspection readiness.Support enhancement of processes related to Risk Based Monitoring, central monitoring activities, protocol deviation management, risk management and TMF Review.Support the creation of processes for internal study management.Support deployment of a systems strategy for tracking of portfolio, program, study and site level metrics, data analytics/trends.Maintain subject matter expertise on relevant topics such as global regulatory/industry activities, trends, and best practices.Support innovative initiatives targeted at understanding organizational needs and improve/revise clinical operations processes locally and globally.Provide input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and on-going adherence to standards and regulations.Support QA in facilitating closure/evidence of completion of assigned Clinical Operations corrective action commitments; confirm that all actions and commitments related to inspections are implemented in accordance with plan.Up to 10% of domestic and/or international travelOther duties and responsibilities as required.

Key Skills, Abilities, and Competencies

Strong knowledge of applicable computer and project management software packages, including Microsoft SuiteKnowledge of current regulatory requirements and guidelines governing clinical research and related terminologyStrong strategic thinking, planning, execution, and communication skillsStrong interpersonal skill set necessary to guide and maintain internal and external collaborator relationships and change management.Challenge the norm with creative solutions.Effective role model with the ability to work in a fast-paced environment.Ability to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity.Fosters open and transparent communication.Demonstrated ability to effectively influence and manage within a matrixed organization.

Requirements

Education, Registration &/Or Certifications:

B.S/B.A. degree is required. Science/health care related field and/or advanced degree preferred but not required

Experience:

6+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.3+ years' experience managing clinical trials. P013025BOSJB_1738251475 To Apply for this Job Click Here