Job Description Summary

The role of the CSM is to support the clinical development of new imaging agents in accordance with ICH-GCP and Standard Operating Procedures (SOPs).
The CSM acts as the Study Manager for assigned small, single country, complex clinical studies and provides the study team with overall direction, clear expectations for deliverables and the leadership necessary for the successful management, conduct and completion of a clinical study
program. Support will be provided from a Clinical Project Director where necessary. To plan, implement and drive all aspects of clinical studies according to the Global Clinical Development Plan (CDP), Product Program Plans and in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOP), Corporate Policies, Guidelines and internal Standards

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Job Description

Roles and Responsibilities

• Ensure that study activities and milestones are planned, agreed and achieved according to the overall clinical development plan (CDP, if applicable), and the corresponding milestone and recruitment plans

• Responsible for the timely and accurate preparation of study documentation such as protocols, amendments, case report forms (CRF)/e-CRFs, study plans and study reports in collaboration with other functions and CROs as required.

• Ensure that the appropriate Regulatory and Ethics Committee submissions and approvals are obtained.

• Participate in the selection of Services Providers /CROs and other external vendors in collaboration with sourcing department / Strategic Alliances Director and study team.

• Select (in collaboration with other functions), supervise and actively manage contractors, consultants and external vendors being part of the clinical study, e.g. Central Lab, EDC vendor, Clinical Research Organization (CRO), ECG vendor, etc. as needed. a. Build strong relationships to maximize performance and value delivered by Service providers b. Create a culture of joint accountability to ensure Vendor performance c. Facilitate efficient and collaborative resolution of problems and conflicts with Service Providers

• Oversee performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits.

• Oversee the tracking of subject enrollment at each trial site and provides management with reports of clinical activities, as requested

• Manage Clinical Study budget

• Identify and communicate areas for improvement within local and global Clinical Research infrastructure at GEHC

• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.

Required Qualifications

• Degree in a science related field with proven experience of clinical study management within the healthcare industry

• Good prior knowledge of all aspects of the clinical study process including planning, execution and reporting/publication of results

• Proven communication skills, both written and verbal, at all levels of an organization

• Must be willing to travel as required, for study team meetings, site visits, client presentations and other professional meetings/conferences as needed. (5%)

Desired Characteristics

• Well organized and structured, attention to detail

• Ability to work independently and systematically

• Diplomatic, cooperative team worker

• Decisive attitude

• Proven ability to manage complex studies and/or multiple studies across different regions

• Proven leadership skills

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. 

While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.

Additional Information