Associate Director, Clinical Operations

Proclinical is seeking an Associate Director to be based in Buckinghamshire on a permanent basis. The Associate Director, Clinical Operations, EU collaborates closely with counterparts in Translational Sciences, and in Data Management & Biostatistics to ensure excellent operational oversight of clinical studies. Providing input to the overall clinical development strategies in the EU, the Associate Director, Clinical Operations may lead the operational team, interfaces effectively with the study vendor and facilitates inter-and intra-departmental communication. The Associate Director, Clinical Operations plans, manages and ensures execution of all tasks during assigned clinical studies from protocol design to final CSR, to produce high-quality study data and to achieve corporate goals on time and on budget.

Job Responsibilities:

• Ensure that all EU rules and regulations are known and adhered to.
• Ensure that CRO is operating in the most efficient way in the EU.
• Provides input to department resourcing and staffing strategies to meet project deliverables and initiatives.
• Collect and gather benchmarking data to support planning of studies, development and activities.
• Participate in study start-up activities including protocol authoring, database design, study manuals, etc. with the mindset of "start with the end in mind" to ensure the operational team is poised for successful data to enable the program strategy.
• Participate in meetings with Finance and Legal for budget and contract discussions for the study vendor and study sites.
• Review total spend for the study, including study vendor and third party labs; manage out of scope tasks and impact on budget.
• Create project plans to prospectively define workstreams and dependencies, owners, due dates and documentation required.
• Manage projects as planned, ensuring studies are rigorously conducted to produce high-quality data, with adherence with relevant SOPs and appropriate regulations.
• Develop/execute project and risk management plans (milestones, metrics) ensuring appropriate escalation as needed.
• Responsible for reviewing, tracking and compliance of study procedures, (i.e. monitoring plan, pharmacy manual, essential document review).
• Further manage projects to ensure studies meet timelines and overall expectations
• Liaise with other team members regularly to maximize communication of issues and status of tasks to improve the effectiveness of the organization.
• Keep team members informed of changes in project status in relation to quality, cost, risk and timelines.
• Be the primary point of contact for Quality Assurance; own CAPAs and lead quality improvement.
• Ability and willingness to travel approximately 20% of the time (international and domestic).
• Other responsibilities may be assigned as required.

Skills and Requirements:

• BS or BA required; MS in the biological sciences (e.g. Biochemistry, Pharmacology) preferred; PMP certification highly desired
• Minimum of 8 years of experience managing EU clinical studies in a pharmaceutical or biotechnology setting
• Experience as a Clinical Research Associate is desired
• Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
• Solid scientific background; able to understand biomarkers and clinical endpoints
• Excellent command of MS Powerpoint, Word, Excel and Project
• Self-motivated and able to function with little supervision
• Highly detail-oriented
• Excellent interpersonal skills
• Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management
• Good team player
• Able to resolve conflicts in a diplomatic manner
• Demonstrated leadership skills
• Ability to manage up and down
• Good negotiation skills
• Solid problem-solving and decision-making skills

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.