What are the responsibilities and job description for the Clinical Trials Management Associate - III position at ALTEN?
Clinical Trials Management Associate - III 3 weeks ago Be among the first 25 applicantsSenior Clinical Trials Management Associate (Sr. CTMA)Must have Vendor Management ExperienceMust have Start-up experience with StudiesSpecific Responsibilities and Skills for Position : Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areasServes as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (Client), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programsContributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research managementProvide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studiesMaintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operationsAssist the CTM to organize and lead review / approval meetings for CO proposalPrioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructionsAble to anticipate obstacles and proactively develop solutions to achieve project goalsDevelop a general understanding of functional issues and routine project goals from an organizational perspectiveParticipate in abstract presentations, oral presentations, and manuscript development activitiesInteract and cooperate with individuals in other functional areas to address routine study issuesDevelop tools and processes that increase measured efficiencies of the projectAssist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs)For Client studies, assist in selecting Contract Research Organizations (CROs) or vendorsAssist with the setting and updating of study timelinesParticipate in departmental or interdepartmental strategic initiatives under general supervisionAssist in review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepanciesConduct site evaluation, initiation, co-monitoring, and closeout visits, in addition to the routine monitoring visitsEnsure that the site complies with the protocol and regulatory requirements for Client studiesFor Client studies, draft and coordinate review of protocols, informed consents, case report forms, and monitoring plansTravel may be requiredKnowledge : Excellent verbal, written, interpersonal and presentation skills are requiredKnowledge of FDA and / or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studiesWorking knowledge and experience with Word, PowerPoint and ExcelExperience and Skills : At least 4 years of experience and a BS or BA in a relevant scientific disciplineAt least 4 years of experience and an RN (2 or 3 year certificate)Seniority level Mid-Senior levelEmployment type Full-timeJob function OtherIndustries IT Services and IT Consulting#J-18808-Ljbffr
