01 Oct Clinical Project Manager – Biopharmaceutical – Surrey
This global biopharmaceutical company is at the forefront of medical innovation to help patients live longer, better quality lives. They focus on developing therapies that will change the course of human health. With offices in 45 countries, they actively seek talented ambitious individuals to contribute to the business. The culture of this business is very much – ingenuity, innovation and independence. Due to growth, they now require a experienced Clinical Project Manager.
- Oversee the performance of CROs, third party vendors, and field CRAs including monitoring
- to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures
- Resolve patient eligibility and protocol deviation issues
- Review monitoring reports for accuracy, completeness and conformance with SOPs.
- Maintains frequent contact with and work effectively with investigators and coordinators.
- Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.
- Responsible for set up and maintenance of the Trial Master File for assigned studies
- Regularly update all trial information databases in order to manage accuracy of information
- Co-ordinate pre-audit activities for nominated projects
- Assurance of regulatory compliance of investigational sites with company SOPs and ICH guidelines.
- Review key study quality metrics and determine appropriate action in conjunction with study team
- 5+ years clinical research experience and a minimum of 2 years project-lead or management experience
- Bachelor’s and/or master’s degree in a scientific discipline or equivalent
- Excellent organizational, leadership and problem-solving skills
- Excellent written and verbal communication skills
- Experience in leading cross-functional teams to meet goals and metrics
- Track record at managing global studies is desirable
- Experience in either the oncology, endocrinology and cardiovascular therapy group a distinct advantage
- Experience in managing Phase I, II, & III clinical studies
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
This is a excellent opportunity to work to well structured, innovative biopharmaceutical organization. Salary is negotiable and will be competitive. They also offer flexible working, holiday entitlement and a performance based share option scheme.
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