Senior Clinical Project Manager, Internal Medicine (Contract, Europe) - IQVIA Biotech

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.