Clinical Project Manager (Early Clinical Development, Home-Based)

IQVIA Inc; Overland Park (KS); Vor Ort; USD 93.000 - 233.000; Vollzeit

Zusammenfassung

IQVIA Biotech in Overland Park, KS seeks an experienced clinical trial program manager to plan, implement and execute contracted activities across regional and global studies. You will lead project teams, maintain client relationships and ensure timelines meet contract requirements.

You will collaborate with management to develop standards, training, and process improvements while complying with FDA, ICH-GCP guidelines and SOPs. Domestic and international travel up to 20% may be required.

Qualifikationen

• Bachelor-level or equivalent in a health-related field.
• Minimum three years clinical trial experience in CRO or related org; one year of management experience.
• Experience in communication, documentation and project coordination.

Aufgaben

• Manage full scope regional and global projects.
• Lead project teams and maintain client relationships.
• Negotiate with clients to ensure processes are maintained and within scope.
• Ensure projects run per SOPs and contract timelines.
• Develop training requirements and assist with process improvements.
• Maintain knowledge of FDA, GCP and ICH guidelines.

Kenntnisse

Clinical research knowledge

Project management

Client relationship management

Communication skills

Organizational skills

Team leadership

MS Office

Ausbildung

Bachelor's degree in health-related field

Tools

Word

Excel

PowerPoint

Electronic data capture

Jobbeschreibung

BASIC FUNCTIONS:

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 and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, 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:

• Knowledge of clinical research process from Phase I through regulatory submission
• Strong communication skills (verbal and written) to express complex ideas
• Excellent 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 various 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
• 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 a minimum of three (3) years direct clinical trial experience in a CRO or research-related organization with at least one (1) year management experience OR Equivalent level of education and experience.
• Previous experience in managing people within a scientific/clinical environment is preferred.
• Clinical Monitoring or Data Management experience required.
• Excellent and demonstrated verbal and written communication and presentation skills.
• 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.
• Experience in contract/timeline management preferred
• Excellent written and verbal communication skills required
• Ability to travel domestically or internationally as required.

CLASSIFICATION: US:

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.