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Assoc Dir, Operations Team (Regulatory Reporting - Home Based)

IQVIA Holdings Inc.

Durham, North Carolina

Job Overview
Lead Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards. Contribute to Global initiatives. Work in close collaboration with SM and other relevant stakeholders supporting the achievement of local and global deliverables and metrics.

Essential Functions
• Ability to track and monitor project financials and budget to ensure agreed margins are maintained
• Ability to independently engage customers on escalation and scope expansion and look for additional business opportunities
• Identify and contribute towards process optimization and automation initiates leading to cost efficiency
• Able to identify and cater to continuous Learning and Development needs of the group
• Contribute and assist in global initiatives e.g. Change Management
• Subject Matter Expert (SME) Committees
• SOP Review Committees
• Retention, Engagement, training, processes etc.
• Create and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment.
• Contribute to, implement and support operational decisions as determined and instructed by senior management.
• Manage Safety Operations staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work
• performance appraisal and professional development guidance
• rewarding and disciplining employees
• addressing employee relations issues
• resolving problems and absence management. Approve actions on human resources matters.
• Management of project resource assignments, staff hiring and staff terminations in collaborations with operations specialist managers. Assists with staff training
• professional and career development.
• Collaborate with other operations specialist’s managers to address problem areas, work scheduling for current and projected projects, staffing needs, equipment needs, and projected peak workloads, ensuring global consistency. Monitor, assess and report utilization of staff. Identify and implement solutions for poor utilization of staff, ensuring global consistency.
• Ensure direct reports are cross trained on Safety service offering
• monitor and develop training plans
• identify training and development needs of staff in collaboration with Training team and Safety Management.
• Lead and encourage direct reports in continuous improvement of department work processes, procedures and infrastructure. Instruct and lead direct reports in efficient management of project budgets through effective timesheet reporting. Work closely with operations specialist managers.
• Monitor and ensure that project processes and department deliverables meet expected quality, financial and productivity targets. Assist with meeting department utilization and realization targets.
• Ensure timely movement of project work through the process steps, in accordance with governing SOPs, ICH/FDA regulations and guidelines, work instructions and client expectations.
• Ensure that staff have been trained on and are following required Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), FDA and ICH guidelines and regulations, Work Instructions and project instructions.
• Work with Safety Management constructively in a matrix framework to achieve project and customer deliverables.
• Perform other duties as assigned.
• Responsible for ensuring 100% compliance towards people practice and processes for self and team

Qualifications
• Bachelor's Degree Scientific or healthcare discipline or allied life sciences
• Bachelor's degree in life sciences or related field and up to 10 years of relevant experience, inclusive of up to 5 years of PV experience and up to 4 years of experience in managing a workforce of up to 100 employees and  or equivalent combination of education, training and experience.
• Demonstrate effective Financial Acumen skills.
• Ability to address large audience during townhalls and other external forums.
• Excellent interpersonal skills, effective communication.
• Engagement with global delivery hubs.
• In-depth knowledge of Safety service lines.
• willingness to increase knowledge across Safety service lines and develop new skills.
• Proven Staff management skills, strong leadership, motivational and influencing skills.
• Ability to work on multiple projects and manage competing priorities.
• Effective mentoring and developed coaching skills.
• Excellent presentation, report writing skills and customer focus skills.
• Ability to achieve results through communication and facilitation in a matrix service delivery environment with shared accountabilities.
• Sound judgment, decision-making and problem solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to support in drafting SOP, Operation, Technical Project documents.
• Ability to understand and analyze performance Metrics and numbers to support operations.
• End to End Project management exposure.
• 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.
• Flexibility to operate in shifts.
• Flexibility to support in global time zones as required.

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.

Job posted: 2020-12-22

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