Program Director, Cardiovascular/Renal/Metabolic-IQVIA Biotech

IQVIA Biotech is seeking a Program Director (Home Based):

BASIC FUNCTIONS:

Manages large global projects and programs and associated project manager teams.  Provision of operational oversight and escalation pathway for project teams. Ensure maximum efficiency and continuity in the conduct of programs of related, parallel or following studies.  

Responsible for the successful strategy development, 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, potentially supported by a team of project managers.  Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors.  Provision of oversight for program operational, financial and quality risk management and mitigation.

Key role in client early engagement activities, provision of response to RFPs, and the development of client proposals including strategy development, budgeting / costs, text development and bid defense meeting leadership. Provides support in client negotiations, internal process implementation, and trend analyses. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages full scope global projects and programs.  Responsible for project team leadership, including provision of oversight to the work of other project management staff.
• Provision of operational oversight and escalation pathway for project teams.
• Responsible for building and maintaining positive client relationships and provision of escalation touch point.
• Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained and projects are done within scope.
• Ability to identify and communicate key strategic risks and build appropriate teams for the development and implementation of mitigating actions.
• Ability to independently resolve project and client related issues.
• Responsible for assuring project timelines are met as per contract.
• 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
• 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

• Performs other duties as required.

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 25% travel may be required including international travel

MINIMUM RECRUITMENT STANDARDS:

• Qualifications and Previous Management Requirements:  Nursing or University degree (US Bachelor level or equivalent) in a health-related field preferred with at least ten (10) years of demonstrated clinical trial project management experience, OR
• Working knowledge of all functional areas of clinical trials management (i.e.: Clinical, DM, Bios, Programming, MW, etc.)
• 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.

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.

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, 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.