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.
The Study Operations Manager’s primary responsibilities are managing the Client Leads and ensuring sponsor satisfaction. Study Operations Manager is responsible for coordinating with peers and subordinates for the overall resourcing of studies. Manages the workload and productivity of assigned team and sponsors. The Study Operations Manager is responsible for tracking project metrics, reporting of findings, escalation of risks and working closely with Client Service Director. Functions as a subject matter expert and point of escalation for Study Operations Leads.
Summary of Essential Job Functions:
- Acts as a process specialist for the Study Operations Leads
- Prepares, arranges and executes regular governance meetings and ensures all necessary materials are prepared with accuracy and completeness
- Identify and execute process improvement initiatives when appropriate
- Manages the assignment of team members to support sponsors and studies
- Ensure support to the sponsors is provided at DrugDev’ levels of excellence through timely resolution of issues that are raised through email and/or phone contact
- Effectively balances workload across the team to ensure contractual commitments are achieved
- Ensures team members are trained and qualified to carry out their responsibilities
- Responsible for development and maintenance of the resource capacity plan and works with Site Operations Manager and Data Operations Manager to ensure appropriate and timely resource levels
- Responsible for monitoring, managing, assisting in resolving and escalating operational issues
- Monitoring and addressing performance metric issues
- Coordinates with the Study Operations Lead(s) to ensure workload is distributed evenly
- Career development planning and performance management for direct reports
- Responsible for achieving established quality and performance standards
- Responsible for implementing process standards across Study Operations Team
- Responsible for performance reviews of direct reports in compliance with HR established performance SOPs
- Other duties as assigned
- Through assigned team:
- Acts as the primary point of contact for assigned sponsor(s) and associated studies
- Responsible for managing the project timeline and identify/pursue change orders and coordinating with the contracts management team
- Identify and execute process improvement initiatives when appropriate
- Prepares, arranges and executes regular client meetings and ensures all necessary materials are prepared with accuracy and completeness
- Function as the engagement leader providing management throughout the length of the clinical trial by overseeing activities of the project team to ensure sponsor commitments and DrugDev’ service levels are achieved.
- Coordinates with Site Operations and Data Operations to ensure proper resource assignment and service delivery quality
- Ensure that DrugDev financial interests are appropriately protected through diligent scope of work management efforts
- Ensure support to the clinical trial sites is provided at DrugDev’ levels of excellence through timely resolution of issues that are raised through email and/or phone contact
- Responsible for ensuring that payments do not exceed SOW timelines
- Responsible for ensuring change orders are executed and communicated to Site Operations Manager and Study Operations Lead
- Responsible for performance review input to Site Operations and Data Operations Management for roles that support assigned sponsor
- Coordinates with the Site Service team members to prepare sponsor funding
- Ensure that all DrugDev processes and standards are followed and that appropriate financial controls are observed and are in line with sponsor requirements for managing and mitigating financial risk
- Ensures work is SSAE 16 compliant where appropriate
- Responsible for monitoring, assist in resolving and escalating operational and performance metric issues
Supervisory Responsibilities: This position has supervisory responsibilities.
- 2+ years management experience in a clinical trial environment
- Bachelor’s Degree in Finance, Business Administration or equivalent experience
- General knowledge of Clinical Trial Industry preferred
- Project management or team leadership experience
- Must be customer focused and have excellent written and oral communication skills
- High energy, self-starter with the ability to work in a team environment as well as independently
- Able to think independently, and to analyze and solve problems creatively
- Strong time management and planning skills
- Detail oriented, analytical and the ability to meet aggressive deadlines
- Comfortable working in a global company environment
- Strong PC skills (i.e. Microsoft Office, Google, MS Project, SAP-Business One)
- Occasional travel”
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
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 [email protected] to arrange for such an accommodation.
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