Senior Clinical Operations Manager - CRO

Posted 07 May 2024
Salary Negotiable
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameRobin Mantell

Job description

Mantell Associates is partnered with a growing CRO organisation in their search for a Senior Manager to join their Clinical Operations team.

Senior Clinical Operations Manager - Responsibilities:

  • Build a Clinical team

  • 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.

Senior Clinical Operations Manager - Requirements:

  • Bachelor's or equivalent degree preferably in Biological Science, Pharmacy or other health / science related discipline

  • Oncology/CNS experience

  • Experience in the set-up and management of phases of clinical development

  • Strong analytical, organisation, negotiation, planning and communication skills

  • Sense of diplomacy, and attention to details, while maintaining a broad overview

  • A high level of integrity and sense of responsibility and professionalism

  • A thorough working understanding of all pertinent regulations, such as those established by local international regulatory authorities as well as the ICH, GCP, and FDA

  • Proven competence in managing project and portfolio priorities, as well as strong interpersonal, analytical, and organisational abilities

  • Expertise in the implementation and use of clinical database software/TMS, as well as other pertinent applications such the Microsoft Office Suite

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.