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

Job Title: Clinical Project Manager (Early Clinical Development, Home-Based)
Job Location: Florence, Kentucky, United States of America
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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
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.
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.

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Originally posted on Himalayas