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BASIC FUNCTIONS:
Ensures the successful planning, implementation and execution of studies and/or programs through direct management, oversight and support. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors. Accountable for strong finance performance and customer satisfaction on assigned accounts.
Participates in business development activities such as early engagements, bid defense and strategy/proposal development. Provides support to divisional leadership in the execution of goals, mentorship and development of staff, internal process improvement, and trend analyses.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
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Serve as primary project oversight and/or contact with customers and own relationship with the project’s key customer contact(s), and may operationally oversee the work of other project management staff.
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Responsible for building and maintaining positive client relationships and keeping all project reporting current and assuring executive management is aware of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting.
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Develop appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and proactively develop innovative solutions to challenges.
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Drive timely execution of work orders and CIS documentation and negotiate with clients as appropriate.
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Assure project timelines are met as per contract and according to SOPs and WP as defined in the contract.
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Develop and/or support on the preparation of study master plans in collaboration with the core project team.
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Supervise problem solving and resolution efforts to include management of risk, contingencies and issues. Take accountability for proactive contingency plans to mitigate risks.
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Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting
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In conjunction with management, may assist with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs/WPs.
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Coach and/or mentor junior team members around project delivery, planning, project review, risk management and problem solving to ensure global alignment of work practices across the team
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Identify and communicate lessons learned and best practices to promote continuous improvement.
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Adopt corporate initiatives and changes and serve as a change advocate and/or SME when necessary.
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Lead the development and delivery of capability and proposal defense presentations to prospective clients, and serve in a functional leadership role to assure client presentations are effective
Participate in the performance appraisal process by providing timely and accurate feedback regarding the performance of respective team members
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Maintain current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research, and personal currency documentation for training, SOPs, CAPA completion and timesheet maintenance
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Responsible for all activities related to implementation of clinical studies, when responsible for project management, including:
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Project team leadership
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Communicating and documenting interactions with clients based on SOPs
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Defining and implementing functional standards, goals, and expectations
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Assuring thorough planning and effective implementation of trials based on contracted scope of work, project timelines, and milestones
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Managing ongoing team activity
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Reviewing project budgets, monitoring costs, potential overruns and implementing cost effective solutions
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Reviewing and identifying project study trends and proactively responding to client and respective team members at least annually
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Developing appropriate early warning systems of impending obstacles to the successful completion of the project, analyzes information and develops innovative solutions to challenges
KNOWLEDGE, SKILLS AND ABILITIES:
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Knowledge of clinical research process
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Strong communication skills (verbal and written) to express complex ideas
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Excellent organizational and interpersonal skills
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Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
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Ability to manage multiple priorities within various clinical trials
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Ability to reason independently for assessing and recommending specific solutions in clinical settings
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Ability to set baseline targets, track trends and implement mitigation plans
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Demonstrated knowledge of electronic data management operations
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Demonstrated knowledge of quality assurance related to clinical trial implementation
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Demonstrated ability to form strong working relationships across functions and regions
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Demonstrated ability to motivate, and lead a project management team
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Demonstrated financial and operational management, negotiation and problem-solving skills
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Experience managing vendors to timelines and contractual obligations
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Extensive experience with monitoring and/or data management supervision according to Good Clinical Practices
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Experience with pharmaceutical product development in a CRO environment
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Excellent knowledge of FDA and/or ICH guidelines for conducting clinical research
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Exceptional ability to conceptualize, develop and manage process solutions and work with clients in all phases or research programs
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
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Very limited physical effort required to perform normal job duties.
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Up to 20% travel may be required including international travel
MINIMUM RECRUITMENT STANDARDS:
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Previous Management Requirements:
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Nursing or University degree (US Bachelor level or equivalent) in a health-related field preferred with at least five (5) years of demonstrated clinical trial project management experience, OR
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Minimum two (2) year degree with equivalent experience, OR
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Within the total years of experience, at least five (5) years clinical trial project management experience in a CRO-related position preferred
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Working knowledge of all functional areas of clinical trials management (i.e.: Clinical, DM, Bios, Programming, MW, etc.)
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Excellent and demonstrated verbal and written communication and presentation skills.
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Excellent demonstrated knowledge of issues affecting data analysis for clinical trials is required.
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Ability to travel domestically and internationally as required.
#LI-BNEGRON
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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