Clinical Operations Manager - CRO

Posted 28 March 2024
Salary Negotiable
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameRobin Mantell

Job description

Mantell Associates is partnered with a growing Clinical Research site in their search for a Manager to join their Clinical Operations team.

Clinical Operations Manager - Responsibilities:

  • Manage vendor relationships and deliver on clinical portfolio

  • Maintain and report on program budgets, such as long-range forecasting and monthly accruals

  • Maintain appropriate standard operating procedures (SOPs) and compliant management of clinical records

  • Be part of a team of internal and external multifunctional stakeholders with a focus on programme management and study execution; assess and create the optimum outsourcing model for clinical portfolio delivery, including control over CROs and other vendors/external partners

  • Ensure strong connections with researchers, key opinion leaders (KOLs), patient advocacy organisations, and regulatory bodies to implement study procedures, provide comments, etc.

  • Work efficiently in collaboration with key subject matter experts in data management, safety/pharmacovigilance, clinical supply and CMC, biostatistics, medical writing, quality assurance, regulatory and medical affairs.

Clinical Operations Manager - Requirements:

  • Minimum of 2 years of experience in clinical research coordination and project management

  • A degree or licensed individual is highly preferred

  • Manage project teams through excellent interpersonal communication skills

  • Experience motivating a group to reach a common goal and working collaboratively

  • Planning and organizational skills should be second nature as well as being attuned and responsive to the patient experience during the trial

  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods

  • Excellent verbal and written communication skills

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.