| Job Description | % of Travel Required : 20-30%
Job Type : Full Time
Career Level : Manager (Manager/Supervisor of Staff)
Education : Bachelor's Degree
Category : Medical Affairs/Clinical
JOB SUMMARY
Manage investigational and post-marketing clinical trials in accordance with clinical development plan. Provide technical knowledge and build clinical research capabilities, implementing appropriate procedures and policies. Actively manage complex projects, including multi-center, multi-vendor clinical trials. Provide clinical input to development project teams, including serving as Clinical representative for Design Control processes. Hire, train, manage, and develop department staff. Identify, select and manage vendors, consultants and Contract Research Organizations (CROs). Develop and maintain relationships with Investigators and their study staff as well as key opinion leaders. Position is in-house and requires approximately 25-40% travel.
KEY RESPONSIBILITIES
Implement and manage clinical development plans and timelines that lead to timely implementation, execution, and analysis of clinical trials in preparation for FDA and EMA regulatory submissions. Identify and manage the activities needed to achieve this goal utilizing internal and external resources. Establish good working relationships with internal legal, medical, clinical, manufacturing operations, regulatory and R&D staff. Prepare clinical documentation to support regulatory submissions. The incumbent will possess an excellent understanding of the clinical development process, ICH GCPs and biologics and medical device regulatory requirements. Good working knowledge of EU medicinal regulations are required; knowledge of ATMP requirements desirable.
Job responsibilities include:
Clinical Study Management
Develop action plans for clinical trials and prepare contingency plans to ensure successful execution
Develop and manage overall trial budgets, contracts and payments
Forecast resource (eg, product, personnel, external vendors) needs and secure funding
Prepare and finalize clinical study documents and obtain internal approvals (eg, Protocol, ICF, IB)
Oversee start-up activities, including Study Manual development
Update internal stakeholders on study progress
Develop and deliver effective presentations for internal and external meetings (eg, Investigator meetings)
Liaise with clinical data management for development of data management and statistical analysis plans
Key contributor to preparation and review of clinical study reports
Manage transparency requirements (ie, www.ClinicalTrials.gov)
Personnel Management
Effectively manage internal/external resources (i.e. interdepartmental teams, vendors)
Facilitate internal and external project specific training
Provide project support for internal and external team members (CRAs etc.)
Ensure level-specific development opportunities are afforded for direct reports
Clinical Operation Infrastructure
Championing continuous improvement efforts
Author/update and review Department Operating Procedures and work/process guidelines
Job Requirements :
5-7 years experience in clinical project/program management experience within a device, biotechnology or pharmaceutical company, or a CRO; including previous monitoring experience of at least 2 years. Biologics or cell-based experience preferred.
B.S./B.A./B.S.N. in a scientific or medical discipline (Biology, Biological Sciences, Biotechnology)
Computer proficiency, including Microsoft Office applications. Experience with EDC systems a plus
Effective oral and written communication
Demonstrated ability to multitask successfully and drive concurrent projects through completion
Possess strong problem solving, organizational, management and interpersonal skills
Work independently with minimal supervision
Effective at prioritizing own and project team work loads
Willingness to travel at approximately 25-40 % with additional travel necessary during certain trial time points and as project needs arise. |
| | Company | | Organogenesis Inc. | Job Code | | State or Province | | Massachusetts | | |
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