Clinical Trial Manager
Managed a new trial duties included: Study Start-up Activities: conducted site feasibility, intricately involved in investigator selection, acquisition of essential documents, negotiated budgets and contracts with sites, chaired and executed team meetings, developed and presented the kick off meeting, managed all aspects but not limited to the vendor contract, scope of work negotiations, and HIPPA agreements).
- Study execution: Managed the CRA team and served as main point of contact for study logistics and related questions including subject eligibility questions.
- Managed study vendors and sites to ensure that key study milestones were met. E.g. Laboratory supplies, reports, drug manufacturing packaging/labeling, supply and distribution, IVRS set up and execution, monitoring time lines, budgets and contracts. By chairing weekly sponsor/project management meetings and teleconferences
- Performed periodic review and revision of departmental policies and SOPs to assure compliance with corporate policies, Good Clinical Practice procedures (GCPs), and ensured compliance with the regulations of local and regional governmental agencies. Maintained professional skills by keeping abreast of literature, attending conferences, courses and meetings/symposia.
- Also responsible for supporting, the Director of Clinical operations on all aspects of clinical trial(s), such as managing interactions with Global Clinical Development Operations, medical monitors, program level activities as assigned.