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
- 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.
US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.