IQVIA Clinical Project Management Director, Respiratory in Detroit, Michigan
Indications of specific interest, i.e., (asthma, COPD, CF, IPF and to a lesser degree respiratory allergy, cough, sinusitis, rhinitis)
Direct and manage large, global, multi functional projects or program, including the execution of the clinical component of the project/program to the Sponsor’s satisfaction, ensuring quality deliverables, on time delivery and within budget. Has strategic decision-making responsibility for the project/program. Ensure that all project work is completed in accordance with SOPs, policies and practices.
Manage the scope of work, objectives, quality of deliverables, and other project and study management activities.
Serve as primary project/program contact with Sponsor to ensure appropriate communication channels are maintained and reporting schedules adhered to.
Ensure the development of project plans for all phases of the project lifecycle, including the quality and risk management, ensuring that issue escalation and resolution is clear.
Develop proactive contingency plans to mitigate clinical risk across studies.
Work with Business Development to finalize the project/program budget and scope of work.
Direct and lead project activities for team members related to their project-oriented tasks to ensure that project/program milestones are met.
Continually review and make recommendations to ensure adequate resources are available to meet project deliverables and milestones
Develop, lead and implement continuous improvement for assigned projects and programs.
Act as the key relationship manager for assigned clients; recommend courses of action regarding client management issues; implement plan following approval by senior management.
Ensuring adherence to change control processes.
Provide consultation to clients on drug development process, study management strategy, and plans as needed.
Participate in proposal and budget development, evaluate feasibility of potential programs and impact on company operations and goals, negotiate and make decisions on behalf of the organization. Participate in sales/proposal presentations in face-to-face meetings with potential clients.
Participate in function and/or corporate initiatives, special project assignments, and as a client liaison or departmental cross-functional liaison.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth technical and/or therapeutic expertise and knowledge of study, project and drug development processes
Demonstrated financial management skills, including project financial tracking and accounting methods
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Excellent communication and interpersonal skills, including good command of English language
Excellent customer management skills
Excellent organization and problem-solving skills
Strong presentation skills
Ability to balance operational and strategic priorities
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
Strong influencing and negotiation skills
Highly effective team leadership skills
Sound judgment and decision making skills
Strong software and computer skills, including MS Office applications
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in life sciences or related field and 12 years clinical research experience including 8 years project management/ leadership experience, including multi-regional and global focus; or equivalent combination of education, training and experience
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
May require occasional travel.
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
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 firstname.lastname@example.org to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
- IQVIA Jobs