Theresa Gregory Email & Phone Number

Horley, England, United Kingdom

Hired to oversee all TMF Operations in a compact biotechnology firm. My responsibilities encompass managing internal clinical systems' business administration, evaluating the clinical portfolio for TMF development opportunities, and executing a strategy for TMF inspection readiness.

During this contract, I collaborated closely with the TMF Operations Manager to create a study TMF oversight and inspection readiness strategy. I was also brought on board to design and execute a new eTMF tool within the Veeva eTMF system. Additionally, I acted as the business administrator for the Veeva eTMF system, where I facilitated change control processes, validation, and user acceptance testing.

Originally hired to join a newly formed team of TMF Managers to ensure essential TMF quality for a dedicated client. Subsequently, promoted to the position of TMF Program Lead, where I had oversight of team of TMF Managers and managed project progression as well as all client relationship interactions. I consistently motivated and empowered all team members to excel in their roles, whilst ensuring their efforts were aligned with organisational and Client objectives.

Uxbridge, Greater London, United Kingdom

Initially, I provided operational support across Phase I to Phase IV studies as a Clinical Study Specialist. My proficiency in managing Trial Master Files (TMFs) captured the rare disease team's interest, leading to my appointment as the TMF Analyst for all TMFs, encompassing both paper and electronic formats, across global rare disease studies. This pivotal role ensured TMF quality and regulatory compliance. Additionally, I led a team of TMF Analysts, focused on supporting an upcoming MHRA inspection.

Maidenhead

London, United Kingdom

London, United Kingdom

London, United Kingdom

Guildford, United Kingdom

Clinical Research Assistant (Professional Training Placement): Jul 2010 - Jun 2011Clinical Research Assistant (Bank): Sep 2011 - Apr 2012

Redhill, United Kingdom