Associate Director Clinical Operations

Hobson Prior are seeking an Associate Director Clinical Operations to join a pharmaceutical organisation on a permanent basis located in Holborn. Our client is focused on fighting against disease and pain.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will be responsible for leading process improvement to support evolving quality systems for global study management and operations.
• Responsible for ensuring operational excellence, and compliance of assigned staff to SOPs, quality standards, and global and local regulatory requirements, including inspection readiness.
• Conduct oneself at all times in accordance with working practices and ICH GCP.
• Leadership of the cross functional Study Team, including functions, Strategic Partners and other vendors, to provide study management and oversight, ensuring study objectives are met, on time and within budget.
• According to Clinical Operations standards, oversee COM's in the development of study management plans including not limited to, sponsor study management & oversight, enrolment models, risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with Strategic Partners.
• May support training, coaching and mentoring of COM's, and CTA's, and on-boarding new hires.
• In collaboration with HCO may provide line management and direct supervision of Clinical Operations Managers (COM's) to execute studies with operational excellence, which may include training & development, performance reviews & talent management.
• Responsible for providing study level updates, including Risks, timelines, & budget to the HCO ensuring that any study issues, with proposed solutions, are escalated as appropriate.
• Be responsible for setting up, implementation and reporting of clinical trial(s) working with the project team and external Service Providers (SPs) /Contractors.
• Manage clinical study/studies according to global regulatory requirements (including but not limited to US CFR, EU CTD, and ICH GCP) and SOPs, and supporting clinical strategy defined in Clinical Study Plan (CSP).
• Be the primary contact for all study operational management related communications with Service Providers (SPs) /Contractors and Development HQ.
• Responsible for providing study level updates, including Risks, timelines, & budget to the HCO ensuring that any study issues, with proposed solutions, are escalated as appropriate.
• Any other assigned duties.

Key Skills:

• Able to interact effectively at all levels within the organisation, as well as with external partners and clients. Good negotiation skills. Strong written and spoken English. Excellent communication skills (verbal and written). Must be diplomatic and tactful in liaising with staff and management.
• Excellent organisational, presentation and time management skills.
• Excellent computer skills in Word, Excel, PowerPoint, email and Internet.
• Proven ability for working independently with minimal supervision.
• Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see and communicate the greater overall picture.
• Strong problem-solving skills, and initiative to drive to solution.
• Experience working in and motivating a team under time and resource pressures to meet objectives.

Requirements:

• A minimum BSc in the life sciences, nursing degree, or equivalent combination of education and experience.
• Significant demonstrated excellence in all phases of global study management, including innovative operations approaches to achieving program goals.
• Significant demonstrable clinical research experience gained within a contract research organisation (CRO), pharmaceutical, or Biotechnology Company, with proven experience of technical and/or project management in conducting multi-national and/or single site early phase clinical trials in a pharmaceutical company or CRO.
• Thorough knowledge of global regulatory and local country requirements including but not limited to US CFR, EU CTD, and ICH GCP, clinical development, and clinical monitoring procedures.
• Demonstrated proficiency with ICH/GCP guidelines.
• Demonstrated excellence in study management, including innovative operations approaches to achieving program goals.
• Demonstrable experience of leading project/study teams. Excellent stakeholder management.
• People management experience; Matrix management, and/or direct.
• Ability to oversee and manage CROs throughout the entire clinical operations life cycle of a study.
• Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
• Proactive approach, a self-starter with a can-do attitude and a willingness to get actively involved from the basics to strategy development and to ensure deadlines are met.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.