Study Operations Manager

Pfizer

Bucharest, Romania

What You Will Achieve

You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope.

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

How You Will Achieve It

Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division;
Oversee the overall execution of clinical studies and be accountable for the development of realistic detailed study startup and monitoring plans;
Oversee and support study start up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget;
Manage full studies for Operational Study Management or manage a unique part of a larger study;
Serve as primary point of contact for study decisions related to the protocol, data collection and volunteer activities;
Approve and oversee drug supply management and manage flow of drug supply to the sites;
Partner with key team members to manage the program to achieve key milestones within time, cost and quality parameters;
Work with functional lines and directly with Contract Research Organization (CRO) line functions to resolve or triage site level issues;
Share and escalate plan deviations to Clinical Project Manager and study team;
Help to address Significant Quality Events or other quality issues at patient and/or site level;
Lead the data integrity and data quality activities for assigned protocols;
Provide regional and cross-regional insights on study-site performance and trends to / from the study team.

Qualifications

Must-Have:

Bachelor's Degree;
5+ years’ experience;
Demonstrated project management/leadership experience;
Experience working in the research and development of pharmaceutical industry;
Experience conducting, managing or participating in regulatory inspection processes;
Knowledge of project management discipline and its application to vaccine development;
Country level cultural awareness and strong interpersonal skills;
Excellent communication skills, both written and verbal in English.