Director of Clinical Studies - Ivyland, United States - LifeLens Technologies Inc.

LifeLens Technologies Inc.
LifeLens Technologies Inc.
Verified Company
Ivyland, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description
LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.


We are seeking an experienced, collaborative, hands-on leader accountable to drive the design, implementation, and execution of clinical development programs that support the LifeLens growth strategies.

This person is a key member of the leadership team and will work cross-functionally within LifeLens and with external partners to ensure evidence-generation programs meet product development (and financial) milestones and requirements for regulatory submissions and market access, reimbursement, and commercialization of the LifeLens Technologies platform.


This is an on-site position. Some travel may be required.

Essential Functions:


  • Leads the design of Clinical Projects including development of trial protocols and budgets, CRO/vendor selection, investigator/site selection, data collection and analysis plans, and publication strategies.
  • Develops collaborative relationships with key investigators and clinical thought leaders. Oversees and attends clinical advisory boards and investigator meetings.
  • Guides and supports operational trial management activities including budgets and timelines, CRO/vendor oversight, site monitoring, and conflict/risk mitigation.
  • Ensures trial operations adhere to clinical protocols and terms of the study and are performed in line with LifeLens' Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).
  • Contributes to and critically reviews regulatory submissions and pre
- / post-submission interactions.

  • Provides Clinical Program updates, including trial status/metrics, budget, accomplishments, and risks to Senior Management and other relevant stakeholders.
  • Collaborates with senior management to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
  • Leads and/or participates in continuous improvement initiatives to ensure SOPs for clinical development and execution facilitate effective clinical research programs and are compliant and evolving with clinical/medical regulations and industry standards.
  • Travels as necessary to facilitate and support clinical trials and investigator interactions

Competencies:


  • Bachelor's degree in a scientific or healthrelated field required.
  • Master's degree in a scientific or healthrelated field is preferred.
  • PMP certification preferred.
  • Minimum of 1012 years of medical device clinical research experience, including onsite monitoring experience.
  • Minimum of eight to ten years of experience in the management of clinical trials as a project manager or other relevant experience at a medtech/pharmaceutical/biotech company or CRO.
  • Minimum of four to six years of prior supervisory experience required.
  • Expert knowledge of FDA regulations and US 21 CFR 820 and EU 13485 quality system requirements required
  • Strong ability to prioritize tasks and keen attention to detail.
  • Excellent written communication, and presentation skills.
  • Demonstrated leadership and project management skills.
  • Proven ability to work on multiple projects in a fastpaced environment.
  • Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.

Benefits:


  • Health Insurance
  • Dental/Vision Insurance
  • Paid Time Off
  • Flextime
  • Stock Option Incentive Plan
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