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Senior Clinical Project Manager

Company name
Novella Clinical

West Jacksonville, FL

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Description Novella Clinical is seeking a Sr. Clinical Project Manager with Oncology and Late Phase experience. BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by Novella and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation of clinical studies including: \u2022Manages projects of full scope regional and global projects. Responsible for project team leadership \u2022Responsible for building and maintaining positive client relationships \u2022Ability to negotiate with clients to assure Novella\u2019s operational processes are maintained, projects are done within scope \u2022Reviewing and identifying project study trends and proactively responding to client and respective team members \u2022Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges \u2022Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements \u2022Responsible for change management on all assigned projects \u2022Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract \u2022Responsible for assuring project timelines are met as per contract \u2022Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead \u2022Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware \u2022In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms. \u2022Provide other project support to Managers, as assigned \u2022Oversee delegation of support staff activities, as necessary \u2022Assists in the development and delivery of capability and proposal defense presentations to prospective clients \u2022Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate. \u2022Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually \u2022Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research. \u2022Responsible to maintain personal currency documentation for Novella SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at each and every instance of out of office KNOWLEDGE, SKILLS AND ABILITIES: \u2022Thorough knowledge of clinical research process from Phase I through regulatory submission \u2022Strong communication skills (verbal and written) to express complex ideas \u2022Excellent and demonstrated organizational and interpersonal skills \u2022Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities \u2022Ability to manage multiple priorities within a variety of complex clinical trials \u2022Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings \u2022Ability to set baseline targets, track trends and implement mitigation plans \u2022Understanding of basic data processing functions, including electronic data capture \u2022Demonstrated problem-solving and financial negotiation skills \u2022Working knowledge of current ICH GCP guidelines CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: \u2022Very limited physical effort required to perform normal job duties. \u2022Up to 20% travel may be required including international travel \u2022Must be able to secure a credit card cosigned by Novella Qualifications MINIMUM RECRUITMENT STANDARDS: \u2022Previous Management Requirements: \uf0d8Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR \uf0d8Equivalent level of education and experience. \uf0d8Previous experience in managing people within a scientific\/clinical environment is required. \u2022Demonstrated Clinical Monitoring and\/or Data Management experience required. \u2022Excellent verbal and written communication and presentation skills required. \u2022Demonstrated financial management skills required \u2022Ability to work independently, prioritize and work with in a matrix team environment is essential. \u2022Working knowledge of Word, Excel, and PowerPoint required. \u2022Prior experience in electronic data capture preferred. \u2022Ability to travel domestically or internationally as required.

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Novella Clinical

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