Location(s): United States; Massachusetts; Marlborough
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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
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
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