Sr./Clinical Trial Manager

The Sr./Clinical Trials Manager (CTM) will support the conduct of clinical trials and data collection and review, monitoring adherence to protocols, and all activities related to trial completion. The Sr./CTM ensures timely conduct of clinical trials according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. The Sr./CTM will interact internally and externally with members of cross functional trial team, and, externally with service providers, investigational site personnel, and others involved in the conduct of the business. The scope of this position requires excellent organizational, communication, and presentation skills, with strong experience in executing all phases of clinical trials. Essential Duties and ResponsibilitiesThe main responsibilities of this role include but are not limited to the following:Manages trial operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s).Supports all aspects of clinical trial management and processes from initiation, planning, execution, maintenance and close-out.Ensure enrollment and data collection are completed in accordance with trial timelines and objectives; escalates risk to timelines and budget as needed.Identifies and provides solutions to clinical trial issues and/or risks.Proactively identifies project risks and resolves with some supervision.Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated.Serve as a liaison and resource for investigational sites.Assists with preparation of RFP's and bid templates to facilitate selection of the CRO's/vendors.CRO Selection: Assist with review of proposals from CROs, review CROs’ SOPs, prepare and recommend CRO to management.Participates in the selection of trial vendors for assigned trials.Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed.Oversee clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, Trial Management Files, communications with investigators, trial site personnel, CRAs, and other CRO/designee personnel.Coordinate the design, format and content of CRFs, trial guides, trial reference binders, patient diaries, and forms including participating in the EDC and specification process and UAT.Contributes to relevant trial documentation including clinical protocols, statistical analysis plan, clinical trial reports as well as operational plans (CMP, DMP).Reviews and refines clinical operational plans including the trial monitoring plan and other study plans as needed.Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.Participates in the selection of investigational sites with input from Clinical Research and vendors.Identify potential trial issues and recommend and implement solutions or corrective actions as needed.Participate in Site Initiation Visits and Co-monitoring Visits for adherence to protocol and GCP as required.Performs other duties as required.