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Project Leader - Nuclear Cardiology

  • GE Healthcare
  • Experienced
  • Posted 5/8/2017 3:46:08 PM
  • 2877063
  • Job Function: Engineering/Technology
  • Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Marlborough

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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:
The Project Leader is responsible for driving cross functional project execution encompassing one or more clinical studies. The initial focus of this role will be to lead the clinical development activities of a Nuclear Cardiology program.

Essential Responsibilities:
He/she develops the Integrated Project Plan and leads the team to successfully deliver the project objectives. He/she ensures that the necessary resources are applied and delivering to plan. He/she provides the project team with overall direction, clear expectations for deliverables and the leadership necessary for the successful management, conduct and completion of clinical study programs. In addition, the Project Leader works with cross-functional teams to ensure product manufacturability, serviceability, safety and quality.

The Project Leader plans, implements and drives all aspects of clinical studies, from feasibility to clinical trial reporting, according to the Clinical Development Plan and in compliance with Good Clinical Practice, Standard Operating Procedures, corporate policies, guidelines and internal standards.

The Project Leader is responsible for managing, maintaining and accurately forecasting clinical project team resources, clinical project subject enrollment and timelines, ensuring high quality image data is generated.

Within the scope of clinical studies under his/her responsibility the Project Leader effectively oversees and/or manages external service providers, external scientific advisory boards or key scientific advisors to ensure their optimal on-time and within budget performance, quality of all deliverables and fulfilment of contractual obligations.

The Project Leader ensures that all aspects of clinical trials, such as laboratories, service providers, and investigational medicinal product supply are appropriately enabled to commence work within the agreed timeframe and to the applicable regulatory/legal requirements.

Responsibilities include (but are not limited to):

  • Ensures that all project activities (internal and external) and milestones are planned, agreed and achieved according to the overall clinical development plan
  • Leads cross-functional project activities
  • Forecasts and tracks internal and external resources and materials for timely NPI project and clinical study execution
  • Manages the conduct, completion, recording and reporting of assigned clinical trials to ensure they are carried out according to relevant GCP standards and regulatory/legal requirements
  • Has responsibility, along with the Medical Director, for the timely and accurate completion of project documentation such as protocols, amendments, case report forms and study reports
  • Identifies risks in meeting study milestones and to address resolutions of the issues with the project team as required
  • Liaises with related functions/departments, e.g. Biometrics, Clinical Study Supplies, Imaging Technology, Regulatory Affairs; Medical Affairs, Portfolio/Program Management, Quality Assurance; Pharmacovigilance; Finance; Contracts; Legal and Compliance
  • Collaborates with the Strategic Alliance Director in their CRO management role and participates in the selection of external providers of clinical services.
  • Ensures compliance in interactions with Healthcare professionals in accordance with company & national policies; ensures compliance with policies on external research studies

Quality/Regulatory Specific Goals:

  • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
  • Complete all planned Quality & Compliance training within the defined deadlines
  • Identify and report any quality or compliance concerns and take immediate corrective action as required
  • Drive compliance/closure of Regulatory and Quality requirements before executing program milestones
  • Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
  • Ensure GCP compliance. Be aware of other relevant regulatory requirements.


  • Bachelor’s degree in a Natural/Life Science field or equivalent
  • A minimum of 3 years Pharmaceutical, Biotech, CRO or Medical Device industry experience
  • At least 3 years’ experience in GCP Clinical trials, preferably as a Clinical Project Manager
  • Work related experience in Clinical Research, ideally within the field of cardiology
  • Experience in working with outsourcing of clinical trials to CROs
  • Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
  • Excellent interpersonal, organization, communication, & influencing skills, able to work with internal and external stakeholders
  • Experience managing complex projects and/or across global regions desirable;
  • Good team player with global mindset
  • Ability to work independently and with rigor
  • Good process knowledge, experience, and skills
  • Customer savvy and understanding of Clinical and Industry environment
  • Technically savvy with experience in risk management
  • Must be willing to travel as required
  • Prior experience working with Microsoft office products (Word, Excel, PowerPoint, Outlook) and MS Project and/or other project management software

Desired Characteristics:

  • Previous experience in clinical development of imaging agents
  • Understanding of PET and Nuclear Medicine imaging trials
  • Previous experience in Nuclear Medicine in Cardiology

Locations: United States; Massachusetts; Marlborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation.  GE is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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