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 IQVIA Biotech 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:
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 IQVIA Biotech’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 IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at 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
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Very limited physical effort required to perform normal job duties.
Up to 20% travel may be required including international travel.
MINIMUM RECRUITMENT STANDARDS:
Previous Management Requirements:
Nursing or University degree 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.