Associate Director, Clinical Operations

Proclinical is working with an emerging biotechnology company that has a newly created Associate Director role, Clinical Operations, to be based in their site in Berkshire. The Associate Director, Clinical Operations oversees the details of complex clinical projects and
contributes to defining the overall program strategy. He/she provides program strategic direction and oversight of clinical research activities, including study design, protocol development, study placement, data collection systems, and final reports throughout all phases of clinical development. He/she is an effective team leader who is able to guide/direct less senior staff to achieve desired results.

Job Responsibilities:

• Meets departmental and project productivity and quality metrics and provides financial and management accountability to a wide range of audiences
• Partners directly with or guides staff to partner with preclinical, regulatory affairs, medical monitor, biometrics, and medical writing to develop protocol and study designs and other key study and program deliverables
• Participates in Protocol, IB, ICF, Regulatory submission documents, CRF, CSR development and review and provides direction to junior staff to manage the process, as necessary
• Effectively discusses and represents study data across the company; collaborates with medical writers and investigators to write, publish and present data
• Develops tracking tools and oversees project budgets, study timelines, and deliverables
• Participates in development of Clinical Operations Plans, Clinical Research Organization (CRO) outsourcing strategy, and key performance indicators (KPIs) with CRO and reviews KPIs during projects.
• Proficient in developing and tracking metrics and assessing clinical operations performance for multiple projects
• Identifies and reports potential program issues and resource deficiencies effectively and in a timely manner and implements corrective action
• Organizes logistics and partners with supply operations to manage clinical trial product supply and labelling of study drug as required by the clinical program
• Assists in the development of global department standards and successful implementation of process improvements and change
• Manages performance, development and growth of junior staff to support and guide them to improved efficiency and effectiveness at prioritization and problem solving; highly experienced as a line manager
• Active participation as a member of the Leadership Team; may be required to represent
• Clinical Operations on cross-functional partner teams

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.