Associate Clinical Trial Manager (FSP)

This Associate Clinical Trial Manager position is responsible for supporting study and site management activities and may include coordination, administration, or management of specific trial activities. An ACTM may also be responsible for a management of some Client clinical trial sites. This role focuses on performing all activities required to evaluate, initiate, monitor and close clinical trial sites.

Organizational Relationships:

• Reports to FSP Line Manager with day-to-day direction from the Client.

• Liaises with cross functional lines as appropriate.

Primary Duties:Assist, or may lead Clinical Trial Management effort to develop, review and track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals.Ensure the Clinical Trial Master System (CTMS) and Trial Master File (TMF) are maintained in an inspection-ready state. Review for compliance and address findings as needed.Track site and study status as assigned.Assess adequacy of potential clinical investigators and clinical trial sites. Includes evaluation of facilities, personnel, patient referral base, and adherence to GCP/ ICH.Train clinical investigators and their personnel in regard to clinical trial protocol and regulatory requirement.Collect and review site essential documents, including site Informed Consent Form (ICF) changesAct as a primary contact with field CRAs, Contract Research Organizations (CROs), vendors, and multiple clinical trial sites.Monitor compliance with the clinical trial protocol, CFR, GCP/ICH guidelines, and overall protocol objectives.Assist with management and accountability of clinical trial supplies, including Investigational Product, research specimen samples and/or radiology scansAssist with management of clinical trial safety and efficacy issuesReview and follow-up of Serious Adverse Event reports.Perform data listings review and generate of data queriesAssist in the preparation and follow-up of in-house and on-site Client sponsored quality audits, as well as, regulatory authority inspections.Conduct clinical team meetings, including agenda preparation, minutes, and action item tracking as assignedEnsure appropriate CRF completion and review and approval of clinical trial site monitoring reportsAssist with the review and analysis of clinical data for clinical trial report generation.Assist with review, approval and reconcilition of clinical trial related invoicesActively contribute to process improvementDemonstrate increased ability to discuss scientific, medical and therapeutic area information.May conduct clinical trial site co-monitoring and independent monitoring visits including: Pre-study,Initiation, Interim Monitoring, and Close-out visits. Follow all outstanding site issues to resolution and/or document attempts to resolve issues upon closure of clinical trial sites.May act as Protocol Lead for small clinical trial, geographical region of large clinical trial, or close-outphase of any clinical trial studyPerform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, Training Guides and other applicable guidelines.QualificationsBA/BS or equivalent or any relevant and qualifying training with a minimum of 4 years of relevantclinical trial management experience. Knowledge of CFR and GCP/ICH requirements is required,Experience on Global Clinical Trials is preferred.Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred)Requires effective organizational and time management skills.Able to multi-task under limited direction and on own initiative.Strong communication and inter-personal skillsHighly responsive and proactive, a team playerTravel up to approx. 20% may be required

#INFSP