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Clinical Trial Manager/Senior Clinical Trial Manager (Science & Biotech)
New York, NY 10018
Recruited by: Sheryl Horowitz | Owner | F-O-R-T-U-N-E Personnel Consultants, Inc. See all my Jobs

  • Hiring Company: F-O-R-T-U-N-E Personnel Consultants, Inc.
  • Industry: Science & Biotech
  • Compensation: Salary
  • Expires: Jun 21, 2020
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Job Description

Our client, a biopharmaceutical company specializing in autoimmune and rare disease, is located in NYC. (The position is office based once things open up again in NYC.) They are currently looking for an experience Clinical Trial Manager, to join the Clinical Operations team! They are a terrific group of people and a stable environment providing growth and a career path for their team!

Key Roles and Responsibilities:
• Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations.
• In collaboration with Sr. Director Clinical Operations, develop study operational strategies including vendor outsourcing approach.
• Assist with management of CROs and third-party vendors in line with study and program goals; including reporting metrics
• Review of study plans and documents to ensure compliance with GCPs, vendor and in-house procedures.
• Participate in site initiation visits
• Participate in co-monitoring visits with the CRO when needed
• Assist clinical sites with questions and resolving queries.
• Ensure complete and inspection ready eTMFs throughout the duration of clinical trials
• Support management of study level budgets
• Support development and follow through of effective clinical and safety data review plans throughout the study; as well as supporting development and implementation of corrective action plans to ensure good data quality
• With oversight from the Sr. Director Clinical Operations, provide support to the multifunctional team and manage vendors to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans.
• Create and improve upon business processes ensure company's successful growth
Requirements:
• BA/BS in a clinical or scientific discipline; at least 3 years of experience with clinical trials; working with a sponsor company (biotech/pharmaceutical company)
• Additional experience in other related fields or positions, some phase 2/3 and global clinical trial experience is a plus.
• Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
• Deep understanding of clinical trial operations and management of clinical trials at investigator sites
• Multitasking ability to oversee a large number of projects and reach milestones on time
• Exceptional academic and professional accomplishments, indicating critical thinking ability
• Strong written and oral communication skills with incredible attention to detail
• Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team