​Mantell Associates is currently partnered with a leading Pharmaceutical organisation in their search for a Head of Clinical Operations.

Head of Clinical Operations - Responsibilities:

• Manage vendor relationships and develop ideal outsourcing model for delivery on clinical portfolio, such as oversight of CROs and other vendors

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

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

• Create and lead 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

• Create and maintain 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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Head of Clinical Operations - Requirements:

• Strong industry experience in all phases of clinical development, with leadership experience in domestic and foreign studies throughout all stages of clinical development

• Degree in business, science or a related discipline

• Strong clinical operational experience for either a biotech or pharmaceutical company

• Demonstrated expertise in CRO/vendor selection and management, forecasting and managing budgets, setting up specific deadlines, assuring the delivery of high-quality data, and producing reports

• 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

• In-depth knowledge of the cross-functional procedures used in research planning and execution, such as protocol preparation, data management, safety/pharmacovigilance, biostatistics, medical writing, quality assurance, and regulatory- and medical- issues

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

• The capacity to lead strategic discussions, inspire and influence others, foster a team-oriented environment, and interact with key internal and external stakeholders, such as the leadership team, principal investigators, key opinion leaders (KOLs), CRO partners, patient advocacy organisations, and regulatory agencies

• 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 +1 (786) 485 1298.