Job Title: Head of Clinical Operations and Data Management
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Vacancy details
Vacancy description:
Job Code:
J078686
Job Title:
Head of Clinical Operations and Data Management
Job Category:
IT & Data Management
Contract:
Locum/Temporary
Discipline:
Data Management, Clinical Data Coordinator
Country:
United Kingdom
Location:
London - Central, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Permanent opportunity for an experienced professional looking for a new Challenge. The title of the role is Head of Clinical Operations and Data Management. You will be covering a wide area including, Clinical Operations, Data Management and Pharmacovigilance and Medical . You will have line managment responsiblities for a few team members and the overall group of people will be around 50.
PURPOSE OF ROLE
To lead and manage the Clinical Operations and Data Management Department to ensure effective and timely delivery of Drug Development Office (DDO) Clinical Trials
To contribute to the overall leadership of the DDO by playing an active role in the senior management team and engendering a culture of continuous improvement, scientific excellence, staff development and forward planning to ensure the DDO delivers its objectives and operates in line with its values and culture statements
KEY AREAS OF RESPONSIBILITY
To ensure effective and timely delivery of Phase I and II trials
To ensure all clinical operations and data management activities comply with legal and regulatory requirements
To ensure close and transparent collaboration between project teams and clinical study teams working in a matrix environment
To ensure regular review and improvement of processes and procedures to optimise speed of development and implement best practice
To ensure appropriate metrics are collected and reported to demonstrate improvements in timelines and performance
Financial and resource management
To set and manage high quality, accurate budgets for clinical operations and data management, ensuring spend is within budget
To manage resources across the various functions of the department and prepare the annual resource plan
Management and Leadership
To develop strong, motivated and productive clinical operations teams (Study management, clinical operations, data management, programming, pharmacovigilance, medical adviser, training)
To act as the line manager for the senior managers within the clinical operations department (approximately 6 staff)
To establish and maintain comprehensive training programmes and documentation for all clinical operations staff
To act as an integral member of the DDO leadership team, aligning the clinical operations and data management team with the company and DDO vision, purpose and goals, and building and maintaining effective interfaces and consistent management across the DDO
To actively participate in the DDO leadership team, developing skill sets and cohesion within the team and supporting other managers in delivering objectives, management team decisions and change
To build and maintain relationships with investigators, stakeholders and other third party customers to create a positive profile of the DDO
PERSON SPECIFICATION
Knowledge and skills
Essentials
• Science graduate, PHD or MD
• Extensive experience of working in a drug development, clinical trial environment in a pharmaceutical, biotech and/or CRO organisation
• Extensive clinical operations management experience, including data management, involving the design and delivery of complex processes to GCP standards
• Extensive team management experience, including working within matrix team systems
• Advanced knowledge of current legal and regulatory requirements for early clinical trials in the UK
Desirables
• Contract negotiation experience
• Experience of early phase trials
• Experience of financial management
Qualities, values and behaviours
• Mature, professional and authoritative
• Self-motivated
• Flexible approach with a “can do” attitude
• Able to lead, motivate and inspire
• Excellent communicator with outstanding written and verbal communication skills
• Excellent interpersonal, organisational and time management skills
• Collaborative and influential with good relationship building skills
• Analytical thinker with demonstrated problem-solving and negotiation skills
• Creative and forward thinking with a proactive approach
• Highly developed project management skills covering complex programmes
• Produces work to a high degree of accuracy and quality
• Unquestionable integrity in the workplace
• Able to work outside normal working hours when required
• Able to travel within the UK and occasionally overseas
Key Words: Director Head Senior Manager Clinical Operations Data Management
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