Clinical Project Manager

Job description

3155933
Additional Cities

Marlborough
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Life Sciences
Function

Engineering/Technology
Country/Territory

United States
Additional States/Provinces

Massachusetts
Postal Code

01752
Role Summary/Purpose

Plan, monitor, and coordinate clinical research studies at external trial sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Corporate Policies, Guidelines and Standards.
Essential Responsibilities

• Participate in selection process of external Service Providers (SPs)
• Build a general understanding of our SPs, their organization and capabilities to anticipate opportunities & risks
• Translate technical requirements from R&D project teams into scope of work for execution by SPs.
• Build strong relationships to maximize performance and value delivered by SPs
• Create a culture of joint accountability to ensure Vendor performance
• Develop, maintain and share Good Vendor Management Practices
• Facilitate efficient and collaborative resolution of problems and conflicts with SPs and on behalf of SPs within Life Sciences.
• Facilitate final quality check for all operational processes associated with specific engagements and accountable for aligning engagement deliverables to GEHC policies and procedures for operations, compliance, and outsourcing
• Facilitate vendor training on applicable GEHC SOPs
• Performs initial contact and participates in the assessment and selection of qualified investigators for inclusion in clinical programs.
• Oversees performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits.
• Contributes to the preparation of study documentation such as protocols, amendments, Case Report Forms, and study reports
• Collects and processes regulatory documents and correspondence.
• Negotiates and tracks center/trial budget according to financial agreement with each centre
• Assists in the tracking of subject enrollment at each trial site, and provides management with detailed reports of clinical activities, as requested
• Ensures that clinical trial sites have adequate supplies to perform the trial
• May supervise the work of more junior Clinical Research Associates

Quality Specific Goals:
1. Aware of and comply with Good Clinical Practice guidelines, 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
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Ensure compliance/closure of Regulatory and Quality requirements before approving Design Outputs/Program Deliverables
5. Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Qualifications/Requirements

1. Degree in a science related field with a minimum of 3-5 years experience with clinical trials management within the healthcare industry or BS with 5-7 years experience in monitoring clinical trials
2. Excellent prior knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results
3. Proven communication skills, both written and verbal, at all levels of an organization
4. Must be willing to travel as required
Desired Characteristics

1. Excellent communication and interpersonal skills
2. Well organized and structured, attention to detail
3. Ability to work independently and systematically
4. Diplomatic, cooperative teamworker
About Us

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than
11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE
Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the
journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge
technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future.
We are accelerating biology to cell therapy in ways no other company can.
Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
Learn More About GE Healthcare – Life
Sciences

Learn More About Careers at GE Healthcare – Life
Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual 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.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening.
Primary Country

United States
Primary State/Province

Massachusetts
Primary City

Marlborough