ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation of clinical studies including:
• Manages projects of full scope regional and global projects. Responsible for project team leadership
• Responsible for building and maintaining positive client relationships
• Ability to negotiate with clients to assure Novella's operational processes are maintained, projects are done within scope
• Reviewing and identifying project study trends and proactively responding to client and respective team members
• Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
• Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
• Responsible for change management on all assigned projects
• Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract
• Responsible for assuring project timelines are met as per contract
• Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
• Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
• In 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.
• Provide other project support to Managers, as assigned
• Oversee delegation of support staff activities, as necessary
• Assists in the development and delivery of capability and proposal defense presentations to prospective clients
• Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate.
• Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
• Responsible 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:
• Thorough knowledge of clinical research process from Phase I through regulatory submission
• Strong communication skills (verbal and written) to express complex ideas
• Excellent and demonstrated organizational and interpersonal skills
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to manage multiple priorities within a variety of complex clinical trials
• Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Understanding of basic data processing functions, including electronic data capture
• Demonstrated problem-solving and financial negotiation skills
• Working knowledge of current ICH GCP guidelines
MINIMUM RECRUITMENT STANDARDS:
• Previous Management Requirements:
• Nursing 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
• Equivalent level of education and experience.
• Previous experience in managing people within a scientific/clinical environment is required.
• Demonstrated Clinical Monitoring and/or Data Management experience required.
• Excellent verbal and written communication and presentation skills required.
• Demonstrated financial management skills required
• Ability to work independently, prioritize and work with in a matrix team environment is essential.
• Working knowledge of Word, Excel, and PowerPoint required.
• Prior experience in electronic data capture preferred.
• Ability to travel domestically or internationally as required.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.