Associate Clinical Project Manager, CVRM (EU) - IQVIA Biotech

IQVIA Biotech is seeking an Associate Clinical Project Manager with experience in Cardiovascular, Metabolic and/or Renal (home-based):

BASIC FUNCTIONS:

Provides project-related support to the Program, Senior, and Project Manager(s) and other project team members from proposal development through final deliverable.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages projects of limited scope (functional or regional).  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 defined in the scope of work
• 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.

• 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.   
• 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 each and every instance of out of office
• May support Director, Project Management, and Project Management team as required by providing appropriate staff management for awarded programs.
• Supports Project or Program Managers with directional insight for Change Orders and Out of Scope work; Assists in communication of budget allocations and approval of invoices.
• Responsible for supporting Project Managers/Program Managers thorough management of project timelines.  Assist/Manage in the development of project timelines and milestone tracking.
• Through matrix reporting, responsible for supporting project teams both administratively and technically as appropriate.
• Participates and assists in the planning and creation of client and investigator meetings and related materials.
• Authorized to:
  • Approve project and pass-thru expenditures up to $25,000.00
• Performs other duties as required.

  KNOWLEDGE, SKILLS AND ABILITIES:

• Good knowledge of clinical research process
• Excellent organizational and interpersonal skills
• Ability to work independently, prioritize and work with in a matrix team environment required.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to handle multiple priorities within multiple, complex clinical trials
• Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
• Extensive working experience with Microsoft Word, Excel, and Power Point
• Strong communication skills (verbal and written) to express complex ideas
• Ability to set baseline targets, track trends and implement mitigation plans
• 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.
• Travel may be required, including international travel
• Must be able to secure a credit card cosigned by IQVIA Biotech

  MINIMUM RECRUITMENT STANDARDS:

• AAS/BS/BA and a minimum of two (2) years related clinical research experience preferred
• Minimum one (1) year management experience
• Experience in contract/timeline management preferred
• Excellent written and verbal communication skills required

  CLASSIFICATION: 

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

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.