Study Operations Manager, office based in Bratislava

Internal Job Description
Job Summary

The Client Service 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.

Experience Requirements

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
Skill Requirements

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

Experience Requirements

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