Phase 1 Clin Res Director/Mgr. of Clinical Ops-Miami, FL

Linden Capital Partners • $100K — $130K *
Miami, FL 33186In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or healthcare-related field
  • 7-10 years of experience in clinical operations, including 5+ years in senior leadership roles
  • Strong understanding of FDA, ICH, and GCP regulations
  • Excellent communication, organizational, and leadership skills
  • Ability to travel as needed and proficiency in relevant software
  • In-depth knowledge of clinical trial operations
  • Experience managing and mentoring a clinical operations team

Responsibilities

  • Lead and mentor the clinical operations team
  • Ensure protocol compliance and uphold quality standards
  • Collaborate with Principal Investigators and Site Directors on studies and enrollment strategies
  • Oversee human resources functions, including staff evaluations and training
  • Monitor protocol adherence and report deviations
  • Coordinate assignment of clinical research coordinators
  • Conduct study closeout procedures

Benefits

  • Health insurance
  • Dental & Vision Insurance
  • Matching 401k Retirement Plan
  • Paid Time Off (PTO)
Full Job Description
Location: This role is onsite at CPMI in Miami, FL

If you are not local to Miami, let's discuss how to get you there!

This is a newly created role at an amazing, top clinical research site located in Miami, FL

About the Role:

We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision.

Responsibilities:
  • Lead and mentor the clinical operations team to promote a collaborative and efficient environment.
  • Ensure protocol compliance and maintain high-quality standards across studies.
  • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.
  • Oversee human resources functions, including staff evaluations, recruitment, and training.
  • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.
  • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.
  • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.
  • Conduct study closeout procedures.
  • Perform additional duties as needed to adapt to the evolving needs of CPMI.
  • Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP

Minimum Qualifications:
  • Bachelor's degree in a scientific or healthcare-related field
  • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.
  • Strong understanding of FDA, ICH, and GCP regulations and guidelines
  • Strong communication, organizational, and leadership skills.
  • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software.
  • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out
  • Experience managing and mentoring a team of clinical operations professionals

Preferred Qualifications:
  • Phase I or early phase experience
  • Bi-lingual in English and Spanish

Benefits Overview:

Our comprehensive benefits package includes:
  • Health insurance
  • Dental & Vision Insurance
  • Matching 401k Retirement Plan
  • Paid Time Off (PTO)

About Linden Capital Partners

Linde plc is a global multinational chemical company founded in Germany and, since 2018, domiciled in Ireland and headquartered in the United Kingdom. Linde is the world's largest industrial gas company by market share and revenue. It serves customers in the healthcare, petroleum refining, manufacturing, food, beverage carbonation, fiber-optics, steel making, aerospace, material handling equipment, chemicals, electronics and water treatment industries. The company's primary business is the manufacturing and distribution of atmospheric gases, including oxygen, nitrogen, argon, rare gases, and process gases, including carbon dioxide, helium, hydrogen, ammonia, electronic gases, specialty gases, and acetylene. The company was formed by the 2018 merger of Linde AG of Germany and Praxair of the United States. The resulting holding company was incorporated in Ireland, with principal executive offices in Guildford, UK. The company is a member of the Hydrogen Council, a group of companies investing in hydrogen vehicles. The company expects hydrogen vehicles to compete with electric vehicles and has invested in wind powered plants that convert water to hydrogen. The company is ranked 444th on the Fortune Global 500 and 178th on the Forbes Global 2000.
Learn more about Linden Capital Partners
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Finance & Insurance
* Ladders Estimates

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