7 months ago
Opportunity to join a small Biotech looking 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.
You'll be responsible for the oversight all data management activities performed by internal and external team members to ensure data integrity, quality, and timeliness is always protected, alongside ensuring on-time achievement of major data management deliverables and milestones.
Proactively escalates critical issues and risks to the study and DM leadership, tracking each item to a resolved state.
Performs weekly review of clinical and vendor data metrics to ensure timely communication of significant data trends to the cross-functional study team and CROs.
Presents with slides at requested study meetings to describe study status, risks, successes, critical metrics, and necessary training.
Reviews and provides input into protocols and other clinical study documents during development.
Reviews and provides development input into all CRO generated DM documentation, such as the Data Management Plan, CRF Completion Guidelines, Data Review Plan, Data Transfer Plans, Data Reconciliation Plans, and other similar files, before providing approval for distribution.
Performs QC of CRO vendor data and SAE reconciliation to provide CRO feedback and negotiate timelines for resolution with the cross-functional process owner.
Leads and participates in cross-functional data review activities.
Executes Project Management and quality oversight for all EDC change management including Protocol Amendment change impact assessment, CRF specifications, Edit Check specifications, CRO QC and validation activities, Sponsor-UAT, and timeline management.
Develops and manages the delivery of data report and listing specifications for data cleaning and Sponsor-clinical data review activities.
Bachelor's degree in scientific/technical discipline
1 year LDM experience in Sponsor-level Oncology data management.
Demonstrated experience in leading Oncology data deliverables to successful completion.
Strong project management skills and ability to lead and collaborate effectively with cross-functional teams.
If this sounds of interest, please reach out to me at 01737 236729 /