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Clinical Manager

Company: Bitsoft International, Inc.
Location: New Haven
Posted on: August 1, 2020

Job Description:

Title Clinical Manager Location New Heavens, CT Duration 12 Months Principal Responsibilities Partner with the OAL(s) to develop and maintain program plans. Ensure tactical program deliverables align to overall program strategy. Facilitates and documents cross-functional team meetings to ensure on time delivery of product supply and key program regulatory CMC milestones. May represent GCSGPSOM on indication or route-of-administration specific Global Program Teams (GPTs). Enables clinical supply execution and operational excellence by implementing program management tools (timelines, minutes, agendas, risk management, etc) and practices to ensure delivery of supply and regulatory filings. Drives execution of the program to achieve goalsobjectives without compromising program deliverables or quality. Proactively manages the program critical path, assesses operational feasibility of strategic plans, and identifies and manages program risk. Manages the program schedule, budget, and resource information to enable efficient and effective CMC portfolio management. Leads operational program management for GO on all alliance co-development programs, including contributing roles on alliance sub-committees and steering committees. Responsible for development and management of the communication plan and stakeholder management plans. Defines and aligns program communications (internal and external) with the Operations Asset Leader and team. Ensure effective, accurate and timely communication of team recommendationsescalations to governance bodies as needed. Manage a team with a diverse array of talents and responsibilities. Work closely with cross-functional teams to plan and develop scope, deliverables, required resources, work plan, budget, and timing for programs. Implement and manage changes to ensure program goals are achieved. Qualifications 5-7 years of related experience in biopharmaceutical industry. Excellent organizational skills with attention to detail coupled with strong interpersonal skills, self-awareness and ability to manage team dynamics. Professional and effective written and oral communication skills. Demonstrated success in leading and negotiating in a matrix-based organization. Demonstrated ability to identify key program risks and develop mitigation strategies and contingency plans. Strong track record in program management in cross-functional drug development teams andor clinical, regulatory, pharmaceutical sciencestechnical operations team(s) in the biopharmaceutical industry. Excellent knowledge of program management discipline and its application to drug development. Demonstrated results in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and fiscal awareness. Knowledge of clinical commercial manufacturing and distribution issues that impact programproduct strategy and planning. Demonstrated ability to facilitate program team meetings, enhance cross-functional communication, support decision making, influence outcomes, and ensure alignment among internal and external stakeholders. Proficiency in core Microsoft software products (e.g., Excel, Word, PowerPoint, and Project). Experience with MS Project online preferred. Education Bachelorsrsquo degree in business or scientific discipline required. Advanced degree andor PMP Certification preferred

Keywords: Bitsoft International, Inc., New Haven , Clinical Manager, Other , New Haven, Connecticut

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