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

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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.

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Senior Clinical Operations Manager - Requirements:

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

• Oncology/CNS experience preferred

• Good site network relations & KOL's essential

• 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

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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.