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.
