UBC - CRA Manager / Clinical Operations Manager
Company: United BioSource Corporation.
Location: London, United Kingdom
Closing Date: 23 Oct 16
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package
Manage the resources (human and material) to provide clinical monitoring services within a designated office or country. Ensure that clinical staff (CSS, CRAs and/or LCRAs) gains the necessary skills and knowledge to perform their respective job responsibilities.
Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.
Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.
Brief Description:Manage the resources (human and material) to provide clinical monitoring services within a designated office or country. Ensure that clinical staff (CSS, CRAs and/or LCRAs) gains the necessary skills and knowledge to perform their respective job responsibilities.
Specific Job Duties:
- Manage staff in accordance with Company policies and applicable regulations
- Responsibilities include planning, assigning, and directing site management and monitoring work
- Appraising performance and guiding professional development; reward and recognition; performance management; addressing employee relations issues and resolving problems.
- Participate in the selection and on-boarding process for new clinical site services staff by conducting candidate review and participating in the interviewing process. Conduct on-boarding training for new staff in conjunction with Human Resources and Learning Management System/ Learning Zone training programs.
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training matrix, and SOP matrix.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies/ trials that are appropriate to their experience and training.
- Operational knowledge of study protocols and Monitoring Plans
- Manage the quality of assigned staff's clinical work through regular review, co- monitoring visits and evaluation of work product and feedback
- Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical site services management.
- May fill in as a CRA or LCRA for a defined project or to assist with milestone achievement on a temporary basis.
- Participate in and initiate process improvement initiatives
- Other duties as assigned by Director, Clinical Site Services, Europe
Supervisory Responsibilities:Supervision of CRAs, Senior CRAs, LCRAs Supervision of CSSs
- Bachelor's degree in a health care or other scientific discipline or educational equivalent; 7 years of clinical trials experience including minimum 3 years’ experience in a leadership capacity; or equivalent combination of education, training and experience
- Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Strong supervisory and leadership skills
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills including good command of English
- Excellent organizational and problem solving skills
- Effective time management skills and ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Some Travel required
NO AGENCIES PLEASE