Assisting Clinical Trial Sponsors
Need Help?
Looking for assistance with your clinical trials?
Do you need an independent expert to review budgets and assist with vendor selection?
Is your outsourced trial taking up too much in-house time?
Feeling nervous about your sponsor responsibilities? Monitoring reports piling up? Unconvinced that your trial sites are audit-ready?
What I can do
Let me help you ........ study start-up, audits/inspections and interim data reviews are all occasions when the project team needs more resources. I am an experienced professional capable of delivering the fast turnaround times that are invaluable to all parties.
I will work with your vendors, relieve your administrative burden, provide pragmatic and unbiased advice to ensure GCP compliance and ultimately increase your comfort level; freeing you up to focus on emerging clinical outcomes and the next steps of development.
Services
CRO/Vendor Management
As well as contracting to commercial sponsor companies, I've worked in CROs, at a central lab and as a study site coordinator. When overseeing project teams from small, medium and large CROs for sponsors of pan-European and global trials of various indications I am the sponsor's advocate but I strive to support the CRO project team.
Project Management
Most recently I have been Clinical Project Manager for a small molecule drug discovery company, managing a long-term oncology study. Previously I managed a number of full-service trials awarded to the micro-CRO I worked for and often performed the dual role of PM and site monitor.
Medical Writing
For ten years I wrote minutes for the annual meeting of a high-level HIV collaboration committee (2006-2016), I have edited numerous protocols and CSRs, written and reviewed SOPs for multiple clients and designed and validated a novel HIV questionnaire in 2011.
testimonials
Regional Medical Affairs Director, Biotech
“Clare Gleeson supported me during the development and initiation of a unique clinical study: a non-product, survey-based investigation of patient and care-giver perceptions. Although industry-sponsored, the study concept and contents depended on cooperation with a steering committee of external academic researchers and clinicians. Clare was assigned the task of coordinating all parties, including the steering committee, the CRO, and the internal clinical operations team. She delivered this with excellence and in a very proactive manner. She kept close contact with me as Study Lead, challenged me if necessary, and kept track of the many parallel activities. Her calm and clear style of communication was valued by all members of the team that consisted of divergent characters and was geographically wide-spread. I am convinced that Clare's contributions to this study were essential for its success”.
Programme Manager, Biopharmaceutical Company
“I have worked with Clare on a number of development projects over the last 10 years, her clinical knowledge has been invaluable. She recognises the constraints and challenges working in a small company environment, maintaining a flexible approach and always being there to answer my questions when I need advice. Her communication style is always very professional and her ability to build relationships has been a real asset”.
Clinical Trials Manager, Private Hospital
"I worked with Clare on a Phase I and a phase IIa clinical trial for over 3 years in my last post. Clare’s role was managing and monitoring the trial for the sponsor while I managed the hospital team. Her standards were high and she pushed our team to deliver high quality data to tight timelines. I found her a pleasure to work with and a real asset during a routine sponsor audit. I remember being shocked when I learned that she was a contractor for the sponsor, since she integrated well, worked hard and took ownership of the job to delivery. I have no hesitation in recommending or hiring Clare and am keen to work with her on future projects.”
Therapeutic Area Safety Head, Pharma Company
"Clare was the Medical Writer for a committee that I sat on, which included regulatory agency, academia, industry and patient groups representation. I was consistently impressed with the quality of the minutes that Clare produced. She had a way of consolidating both scientific content and extensive, and sometimes contentious, discussions into an accurate summary that satisfied all stakeholders on the committee."