Director of Research Clinical Trials Administrator - New York, United States - Mount Sinai

Mount Sinai
Mount Sinai
Verified Company
New York, United States

3 weeks ago

Mark Lane

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Mark Lane

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Description

Description

The Director of Research Administration is responsible for defining the clinical trial strategy and financial management of clinical studies conducted for the assigned department.

This individual manages operational and logístical tasks of clinical development to ensure efficient execution of trials within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations, including FDA regulations, IND, IDE, 510 (k) guidelines etc.

The Director coordinates the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.


Responsibilities

  • Set strategic direction and leads large clinical trials.
  • Manage clinical research and operations including design and initiation of clinical trials to optimize tactical and clinical value through global site selection and data portability.
  • Coordinate and oversee clinical trials to support regulatory submissions (IND) as well as postmarket clinical trials and clinical preference evaluations
  • Assist in training the clinical sites to the protocol.
  • Work with trial sites to ensure expedient patient recruitment in conjunction with CRO.
  • Author and/or work with others to develop publications based on the results of the clinical trials.
  • Provide updates and status reports to senior management on a regular basis; report on performance against plan.
  • Manage the budget for clinical trials. Ensure overall operation is within the approved budget and timeline.
  • Develop and implement policies and procedures for clinical trials and related activities.
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.
  • Develop and maintain professional relationships with academic and communitybased physicians, clinicians and investigators to assure good clinical input to ISCIs product development process, and marketing.
  • Interface with departments within and outside including Reimbursement, R&D, Regulatory Affairs.
  • Manage staff and outside partners/service providers.
  • Represent the department at major annual conferences

Qualifications

  • Bachelors degree required; Natural or Health Science preferred; Masters degree in related field preferred.
  • 10+ years of experience in, medical device or pharmaceutical industry with at least five years of handson managerial experience running clinical trials and managing teams.
  • Experience with all aspects of management of large clinical trials from inception to completion.
  • Strong knowledge of FDA regulations and experience with IDE Trials.
  • Previous clinical trial site management experience.

Employer Description

Strength Through Diversity
The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care.

When you join us, you become a part of Mount Sinai's unrivaled record of achievement, education, and advancement as we revolutionize medicine together.

We invite you to participate actively as a part of the Mount Sinai Health System team by:


  • Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
  • Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing sidebyside in support of colleagues who experience discrimination.
  • Inspiring and fostering an environment of antiracist behaviors among and between departments and coworkers.


We work hard to acquire and retain the best people and to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to professional advance.

We share the belief that all employees, regardless of job title or expertise contribute to the patient experience and quality of patient care.

Explore more about this opportunity and how you can help us write a new chapter in our history


"About the Mount Sinai Health System:
The Mount Sinai Health System is an equal opportunity employer.

We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression.

We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve.

Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.

"


EOE Minorities/Women/Disabled/Veterans

Compensation
The Mount Sinai Health System (MSHS) provides a salary rang
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