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I'm working with a company to advance the science of oncolytic immunotherapy improving both existing therapies and helping treat more patients with a variety of tumour types. Their oncolytic immunotherapies have the potential to redefine the cancer treatment paradigm through igniting a patient-specific anti-tumour immune response both locally at the site of the injected tumour and systemically throughout the body.
They'll be responsible for the oversight of clinical data management activities for all phases of clinical trials and programs and serve as the internal expert in all areas of clinical data management processes and technology and leads and/or contributes to company process improvement initiatives.
Responsible for DM/ vendor oversight at company level
Review/Management of DM activities in vendor proposals, budgets and scopes of work
Reviews and provide input into protocols, SAP, IB, CSR and other clinical study documents during development
May function as internal DM Study lead, if needed, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; Work to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions
Oversee or lead internal study team in data review; Perform data review for quality issues and general data trends. Provide guidance to others on program-level internal data review standards
Work with Biostatistician/SAS programmer and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports
Lead development and implementation of departmental initiatives (e.g. standard eCRFs).
Lead development and/or improvement of data management SOPs and guidelines
Bachelor's degree in scientific/technical discipline
10+ years of relevant work experience with a focus on data management in a biopharma or biopharma services company
2-3+ years of experience successfully managing a data management team required
Expertise in clinical oncology indications, end points, data flow, data integrity, standards and data quality
If this sounds of interest, please reach out to me at 01737 236729 /