Experience

Accellacare

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Trial Manager

  • Mar 2019 - Present

  *Lead study with administration, coordination amd management of study activities * Manage study project plans adhering to study commitments and timelines *Development of study specific logistics and documentation for review and approval by sponsor * Relationship management with sponsor, CRO, investigative site staff, laboratory, pharmacy and other internal and external personnel * Participate in sponsor IM’s and SIV’s * Project calls, webinarsm teleconferences and meetings * Scheduling training, conducting training with subcontracted clinicians * Entry into CRM and review of study CRM reports * Pre-visit and post-visit follow up with clinicans * Review of study documentation for accuracy, completeness and turnaround times; solicit information to support inquiries * Filing of study communications handle, sensitive issues effectively * Ensure high satisfaction of all stakeholders * Ensure visits are not missed, documentation is timely, complete and accurate and lab samples are evaluable * Comply with ICH/GCP, IATA, HIPAA, data privacy and other appropriate regulations Show less