Danielle Maas Email & Phone Number

England, United Kingdom

London Area, United Kingdom

We're a next gen CRO running end-to-end clinical trials for health and biotech pioneers.

I currently work as a Clinical Trial Manager on the STREAM trial, a complex stage III international Tuberculosis trial. My role is somewhat of a hybrid between operational trial management and quality management, as I provide the day-to-day coordination of the trial for sites in India and Uganda, acting as a first point of contact for any operational queries, but I also provide vendor management and oversight of third parties, who are responsible for providing monitoring services. I work within a diverse team of experienced medical professionals, bio statisticians, clinical staff and operations staff, coordinating across cross-functional groups in order to effectively deliver the trial to patients. Key responsibilities: • First point of contact for all operation aspects of the trial for Indian and Ugandan sites, providing coordination and implementation of the trial in line with the study protocol, SOPs and relevant regulatory requirements by liaising with a diverse team of collaborators. • Providing input into the development of the trial protocol and patient facing documents such as the informed consent form and patient information sheets. • Providing insight and input into trial specific working process documents such as the quality management plan. • Responsible for compiling and presenting relevant reports for internal stakeholder meetings• Responsible for third party vendor management of IQVIA and related subsidiary companies• Developing and implementing new oversight processes, such as onward PD reporting and remote source data verification.

I had an extremely diverse role at SITU. First, I was a Clinical Trial Coordinator for a portfolio of trials across Oncology, Critical care and Orthopaedic surgery, responsible for all operational aspects of these trials. However, I also acted up as associate operations manager for a period of time alongside this, to oversee and bring in new business opportunities for the unit. Key responsibilities:• Responsible for the day-to-day management and conduct of a portfolio of five clinical trials (CTIMP and non-CTIMP), working across oncology (prostate, breast & head & neck), critical care and orthopaedic surgery therapeutic areas within the UK, Europe and Canada. • Also responsible for the co-ordination of grant submissions for upcoming projects for both commercial and research council grant calls. Duties included calculation of trial budgets, liaison with key stakeholders, justifying resources and ensuring timely set up of research contracts, following a successful funding outcome. • Responsible for the coordination and management of multi-disciplinary site teams of between 5-15 staff members, in order to successfully deliver projects to time and budget. • Ensuring that all sites correctly adhere to the trial protocol and principles of ICH/GCP and other relevant regulatory requirements.• Writing and dissemination of approved trial related documentation including protocols, data management plans, Standard Operating Procedures, monitoring plans and other essential documentation. • Preparation and submission of both minor and substantial amendments• Preparation and conduct of training of sites, including Site Initiation Visits • Co-applicant on an NIHR Research for Patient Benefit grant for a plastic surgery trial

London, United Kingdom

London, United Kingdom