Senior Clinical Project Manager, Dermatology, Home-Based - IQVIA Biotech
We are looking for a candidate with a strong Project Management background working with a CRO (Clinical Research Organization). Dermatology experience is preferred.
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
- 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
- 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
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
- Must be able to secure a credit card cosigned by IQVIA Biotech
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.
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