Clinical Project Director
Remote
The CPD acts as the Study Manager for assigned large, global and/or 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. 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
Determine the feasibility for running a clinical study in collaboration with other functions as required.
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.
Ensure that (Serious) Adverse Event ((S)AE) reporting is performed in compliance with internal and external (S)AE reporting requirements.
Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO.
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.
Build strong relationships to maximize performance and value delivered by Service providers
Create a culture of joint accountability to ensure Vendor performance
Facilitate efficient and collaborative resolution of problems and conflicts with Service Providers
Facilitate vendor training on applicable GEHC SOPs
Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs.
Oversee performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits.
Oversee negotiation and tracking of site budget according to financial agreement with each site
Oversee the tracking of subject enrollment at each trial site and provides management with reports of clinical activities, as requested
Ensure that clinical trial sites have adequate supplies to perform the trial
May supervise the work of less experienced study managers
Manage Clinical Study budget
Attend monthly Clinical Research Meeting to report on progress of their assigned study/ies
Participate in the development and review process of globalization and harmonization such as Standard Operating Procedures, guidelines, and forms.
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.
Make sure daily operation of clinical study is in line with QA system and regulation, and ensures the project team maintains a continuous state of audit readiness.
In collaboration with the Medical Director, identify study committee members (such as steering committee, publication committee), ensure contracts and charters in place and ongoing oversight and management is performed.
Attend Competent Authority/Ethics Committee study review meetings as required.
Required Qualifications
Master's degree from an accredited university or college with 3 at least 3 years' experience running clinical studies OR a high school diploma / GED with at least 6 years of experience.
Excellent prior knowledge of all aspects of the clinical study process including planning, execution and reporting/publication of results.
Must be willing to travel as required, for study team meetings, site visits, client presentations and other professional meetings/conferences as needed.
Desired Characteristics
Excellent written and oral communication skills, interpersonal skills and good presentation skills.
Imaging studies experience.
Well organized and structured, attention to detail.
Ability to work independently and systematically.
Diplomatic, cooperative team worker.
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.
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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.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
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.
Relocation Assistance Provided: No
Application Deadline: July 03, 2024 ApplyJob Profile
Legal authorization to work in the U.S. is required U.S. based positions only
Benefits/Perks401(k) Plan Accident Insurance Challenging careers Competitive benefits package Competitive compensation Dental Life, disability, and accident insurance Medical Medical, Dental, Vision Paid Time Off Professional development Tuition reimbursement Vision
Tasks- Manage vendor selection and relationships
- Oversee site visits and budget
- Plan and implement clinical studies
- Prepare study documentation
- Report on study progress
- Supervise study team
Clinical Development Clinical Research Clinical trials Collaboration Communication Compliance Documentation GCP Leadership Medical Imaging Negotiation Presentation Process Regulatory Submissions Service SOPS Training Vendor Management
EducationAS Business GED High school diploma Master's Master's degree
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9