Associate Director, Clinical Leads

PURPOSE

Focus is on leveraging deep operational expertise and IQVIA suite of solutions to drive operational excellence and high quality delivery for our customers. Direct and manage an assigned team of Clinical Leads staff who lead or support studies or programs to ensure quality, time and budget deliverables are met to the Sponsor’s satisfaction and in accordance with SOPs, policies and practices. Ensure employees are trained and individual development is aligned and in place to meet project and organizational needs.

RESPONSIBILITIES

• Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
• Work with the Clinical Leads to ensure patient recruitment, project budget(s) meet financial and company goals (realization targets), with a focus on adherence to change control processes.
• Ensure all study management and project deliverables are completed per the agreed strategy and contract. Achieve quality deliverables on time and within budget and in accordance with SOPs, policies and practices with a primary focus on timely patient recruitment.
• Provide effective and timely consultation/guidance to Clinical Leads on issue resolution.
• Serve as a Clinical Lead liaison with other groups within IQVIA.
• Drive consistency of operational delivery across customer’s projects/programs; ensure plans are implemented following approval by senior management.
• Provide consultation to clients on drug development process, strategy, and plans as needed, in particular around patient recruitment. Maintain current product and project knowledge.
• Collaborate with other management and leadership team members to proactively identify resourcing solutions and project and/or individual needs in order to manage studies.
• Work with individual staff to identify any quality issues within the study and provide coaching on resolution of issues, including implementation of corrective and preventative action plans and escalation.
• Direct, manage and mentor an assigned team of Clinical Lead staff who lead or support studies or programs. Actively provide guidance/coaching around project planning, project review, risk management and problem solving to achieve global alignment of work practices across the team through the adoption and use of all process and technology tools and improvements by employees.
• Support the sales process and participate in bid defense meetings.
• May serve as a back-up on projects as needed.
• Participate in and champion function and/or corporate initiatives, changes and/or special project assignments; act as a client liaison, departmental cross-functional liaison and/or change agent; provide technical expertise and clinical project management experience to project management and training and process improvement efforts.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• 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
• Broad protocol knowledge; therapeutic knowledge desired
• Strong understanding of Clinical Research industry (drug/device/ technology/etc.) and the relevant environments in which it operates
• Strong understanding of the competitive environment and how to communicate/demonstrate value through IQVIA solutions
• Strong understanding of other IQVIA functions and their inter-relationship with Project Leadership
• In depth understanding of project management practices and strong history of demonstrated project management capabilities
• In depth understanding of, and experience managing, contractual obligations and implications
• Demonstrated strong understanding of project financials and managing project P&L
• Proven ability to manage a team and work through others in a global environment to deliver results to the appropriate quality and timeline metrics. Provides others with a clear direction; delegates work appropriately and fairly; motivates and empowers others; monitors/manages performance and provides feedback and coaching; recruits, develops and retains staff of a high caliber
• Excellent customer service skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, and negotiate solutions
• Ability to manage competing priorities
• Good judgment and decision making skills
• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
• Strong presentation skills
• Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
• Excellent communication skills, including good command of English language
• Strong software and computer skills, including MS Office applications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor's degree in life sciences or related field and 10 years clinical research experience including 6 years in a leadership capacity; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

• 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 workday_recruiting@iqvia.com to arrange for such an accommodation.