Permanent Oncology Study Manager within a growing Biotech Company.
Introduction:
This Company pioneered the development of novel products based on the advances in recombinant DNA and molecular biology and launched the biotech industry's first blockbuster medicines. The remit of this role is to support the design and management of operational activities related to the planning, implementation and reporting of oncology clinical trials. This role is office-based in Cambs., but the company offers a scheme for flexible working arrangements after three months service.
Summary of Duties:
Review study related documentation, including; Study Concept Document, Feasibility documentation, Protocol, Study Plans, Safety related documents,Clinical Study Report and publications
Organise and where appropriate, lead Investigator, Study co-coordinator and CRA meetings
Line management responsibilities of Associates and Senior Associates
Mentor, training and career development of staff
Oversee the identification, selection, set-up, and management of CROs and vendors, including approval of invoices
Monitor the execution of the clinical study against the specified timelines, deliverables, and budget
Resolve patient eligibility and protocol deviation issues
Resolve issues arising from patient medical management
Monitor completion of study data collection, analysis, and closure
Contribute to the review and interpretation of study results
Qualifications & Skills:
BSc (LifeSciences) or Nursing Qualification
Ideally a further degree
Prior experience in oversight of clinical research vendors (CROs, central labs, imaging vendors etc
Project planning experience including oversight of study deliverables, budgets, and timelines
Experience writing and presenting clearly on scientific and clinical issues
Experience collaborating and leading cross-functional teams (team/matrix environment)
Fluent in English