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

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