Clinical Project Management Director, CNS (Home-based) - IQVIA Biotech

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

IQVIA Biotech, a full service CRO, specializing in providing high touch services designed to help emerging biotech companies move forward in their effort to get treatments to patients, is actively seeking a well versed Clinical Project Management Director. Ideally, candidates should have a minimum of 10 years of industry experience, the majority of that time being dedicated to clinical project management. This opportunity is seeking candidates with strong Central Nervous System (CNS) experience. It is a remote position and can be located anywhere in the US. A solid background within a CRO environment is required.

BASIC FUNCTIONS:

Manages projects of full scope regional and global programs.  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 (GCP) and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement

Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

Key role in the development of client proposals including both costs and textual support. Provides support in client negotiations, internal process implementation, and trend analyses. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages projects of full scope regional and global programs.  Responsible for project team leadership. May operationally oversee the work of other project management staff.
• Responsible for building and maintaining positive client relationships and keeping all project reporting current and assuring executive management is aware of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting.
• Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained and 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.
• Identify, define, document in requirements in LMS systems and assure project level compliance with study specific training requirements.
• Responsible for change management on all assigned projects.
• Ability to independently resolve project related issues.
• Responsible for assuring projects assigned are run according to SOPs and WP as defined in the contract.
• Responsible for assuring project timelines are met as per contract.
• Responsible for identifying study processes which need to be created or 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 of issues putting IQVIA Biotech at financial or regulatory risk through the approved upon pathways for reporting
• 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.
• Assists in communication of budget allocations and approval of invoices.
• Provide other project support to Managers, as assigned.
• Oversee delegation of support staff activities, as necessary.
• Provides required and supplemental training to staff. Provides ongoing feedback regarding staff performance and assesses performance at least annually with quarterly documented review of goals. Makes recommendations regarding salary adjustments.
• Assures compliance with Good Clinical Practices (GCP) within all Clinical Program Services (CPS) functional areas.
• Responsible for identifying processes which need updating and documenting that to the divisional lead.
• Leads the development and delivery of capability and proposal defense presentations to prospective clients. Takes a cross functional leadership role in assuring client presentations are effective
• Ability to present personal skills and IQVIA Biotech capabilities in any client presentation resulting in work awards.
• 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. In addition, responsible to assure currency for those within the Program Director’s reporting line
• Performs other duties as required.
• Authorized to:

• Negotiate deliverable timelines with clients leading to contract amendments
• Negotiate scope of work agreement with clients as per company policy
• Approve project direct and pass-thru expenditure as per company policy

• Responsible for all activities related to implementation of clinical studies, when responsible for project management, including:

• Project team leadership
• Communicating and documenting interactions with clients based on SOPs
• Defining and implementing functional standards, goals, and expectations
• Assuring thorough planning and effective implementation of trials based on contracted scope of work, project timelines, and milestones
• Managing ongoing team activity
• Reviewing project budgets, monitoring costs, potential overruns and implementing cost effective solutions
• Reviewing and identifying project study trends and proactively responding to client and respective team members at least annually
• Developing appropriate early warning systems of impending obstacles to the successful completion of the project, analyzes information and develops innovative solutions to challenges

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of clinical research process
• 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 assessing and recommending specific solutions in clinical settings
• Ability to set baseline targets, track trends and implement mitigation plans
• Demonstrated knowledge of electronic data management operations
• Demonstrated knowledge of quality assurance related to clinical trial implementation
• Demonstrated ability to form strong working relationships across functional boundaries
• Demonstrated ability to motivate, and lead a project management team
• Demonstrated financial and operational management, negotiation and problem-solving skills 
• Extensive experience with monitoring and/or data management supervision according to Good Clinical Practices
• Experience with pharmaceutical product development in a CRO environment
• Excellent knowledge of FDA and/or ICH guidelines for conducting clinical research
• Exceptional ability to conceptualize, develop and manage process solutions and work with clients in all phases or research programs

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

MINIMUM RECRUITMENT STANDARDS:

• Previous Management Requirements:

• Nursing or University degree (US Bachelor level or equivalent) in a health-related field preferred with at least five (5) years of demonstrated clinical trial project management experience, OR
• Minimum two (2) year degree with equivalent experience, OR
• Within the total years of experience, at least five (5) years clinical trial project management experience in a CRO-related position preferred

• Working knowledge of all functional areas of clinical trials management (i.e.: Clinical, DM, Bios, Programming, MW, etc.)
• Clinical Monitoring or Data Management experience required. 
• Excellent and demonstrated verbal and written communication and presentation skills. 
• Excellent demonstrated knowledge of issues affecting data analysis for clinical trials is required. 
• Ability to travel domestically and internationally as required.

CLASSIFICATION:

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

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IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.