Senior Clinical Operations Specialist

  • Job posted by Cohen Veterans Bioscience

Job Type

Full Time

Published

10/10/2018

Address

311 West 43rd Street
New York
New York
10036
United States

Description

Senior Clinical Operations Specialist

Cohen Veterans Bioscience (CVB) is looking for an experienced full-time Senior Clinical Operations Specialist to work in our NY City office (311 W 43rd St) The Senior Clinical Operations Specialist should have substantial drug development and clinical trials experience, preferably in Central Nervous System conditions, to drive CVB-sponsored clinical trials forward.


Responsibilities

  • Ensure consistency, quality and compliance with global clinical standards
  • Oversee the preparation and management of clinical trial budgets and timelines
  • Track study progress, identify potential issues and proactively recommend mitigation plans
  • Provide input into the content and execution of Investigator Meetings
  • Participate in developing Clinical Sites training plans
  • Contribute to and oversee the development of Study Manuals and other and other trial documentation
  • Participate in drafting informed consent templates and reviewing documents for IRB submissions
  • Contribute to recruitment strategies and execution with oversight, provide point of contact for escalated site questions relating to study conduct
  • Drive and contribute to the evaluation, selection, and management of CROs and other clinical trial vendors
  • Recommend and help establish clinical trial systems and processes, including documentation, QA, partnerships with CROs, investigator sites and physicians
  • Participate in the development and implementation of other key organizational process improvement initiatives
  • Other responsibilities as assigned


Qualification

  • Undergraduate degree required, advanced degree (PhD or PharmD) highly preferred
  • Extensive experience (at least 5 years) in clinical trial conduct within the biopharmaceutical industry, preferably in Neurology and Psychiatry
  • Must have a strong working knowledge of event management, project budgets, and customer relations
  • Must be familiar with fundraising and increasing revenue while maintaining a comprehensive and cohesive brand and identity
  • Must be comfortable with public speaking and communicating both verbally and in writing
  • Must be able to multitask with event projects, data analysis, and coordination
  • Must be willing to challenge the standard thinking with new ideas, new approaches, and new solutions.
  • Must have strong decision-making skills and the determination to see projects through to the end.
  • Demonstrated skills in leadership, management, and collaboration.
  • Must be self-directed and able to work independently.
  • Proven ability to quickly earn the trust of key stakeholders; mobilize and motivate teams.
  • Must have proficiency with Microsoft Office PPT, Word, Excel and Project Management Tracking software.
  • Excellent English communication, negotiation, and interpersonal skills.
  • Familiarity with the Drug Development Process is preferred.
  • Candidate must possess excellent team building, training and facilitation skills.
  • Vendor experience with contracts/negotiation is required.


About CVB

Cohen Veterans Bioscience is a national, nonpartisan research 501(c)(3) organization dedicated to fast-tracking the development of diagnostic tests and personalized therapeutics for the millions of veterans and civilians who suffer the devastating effects of trauma-related and other brain disorders.


To Apply

We offer a highly competitive salary commensurate with experience and a full benefit package.


Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. CVB is an Equal Opportunity Employer.

Professional Level

None specified

Minimum Education Required

No requirement

How To Apply

https://cohenveteransbioscience.applicantpro.com

Please visit https://cohenveteransbioscience.applicantpro.com to apply. Please include resume, cover letter, and salary requirements. CVB is an Equal Opportunity Employer.


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