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Clinical Program Manager

Location: Marlborough, MA
Date Posted: 11-29-2018
)            Ideally the candidate will have worked within a CRO (Clinical Research Organisation) or Pharma Company previously.
2)            I would prefer someone who has been a CRA in the past and has already performed a role as a Clinical Project Manager, but I will consider people who are Lead CRAs.
3)            This person must know and understand what GCP (Good Clinical Practice) is as this is very specific to the Pharmaceutical industry and will ensure that we are looking at Clinical Project Managers with correct project management background.
4)            This person should have experience overseeing vendors.
5)            They should be able to review IRB submission packages, review and approve site contract budgets and follow industry standard project plans.
 
 
Role Summary : Description:
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.
 
 
Responsibilities : Duties include (but are not limited to):
•             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

 
Qualifications:
1. Masters/Degree in a science related field with a minimum of 5-7 years experience with clinical trials management within the healthcare industry or BSc, with additionally 7-10 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
 
 
U.S. (Country) Specific Qualifications:
1. Must be legally authorized to work in the United States full-time
2. Must be willing to work in our [city, state] facility full-time
3
 
Preferred Qualifications:
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
GE Healthcare provides transformational medical technologies that are helping a new age of patient care. GE Healthcare’s expertise in medical imagine and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in health and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
 
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