Essential Functions
● Complete appropriate role-specific training to perform job duties.;
● Under supervision, provides study level administrative support to the clinical study management team (examples of such tasks include, but not limited to running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues, etc.).;
● Assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis.;
● Perform the activities as per the task list delegated by CMS leads.;
● Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies, by pulling associated reports.;
● Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;
● Prepare i-site pack for respective sites and countries for assigned studies.;
● Interact with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc.;
● Establish and maintain effective project/site communication.;
● Assist leads in maintenance of internal systems, databases, tracking tools and project plans.;
● Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
● Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.). Review any other information as necessary to determine overall readiness of the patient information for next level review.;
● Perform Study specific analytics based on applicable study specific plans.
● Perform assigned access management related administrative tasks to support team members with project execution, example of tasks includes but not limited to processing access requests, following up with relevant vendors, assigning catalog task to process associates, etc.;
● Act as a backup for Centralized Monitors/Sr. Centralized Monitors.;
● Provide support to the technical solution specialist (TSS) on formulations in Excel, automations of tool using macros codes and designing of the tool on the front end and back end.;
● Facilitating early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
● Monitor site performance and make recommendations for timely corrective actions (eg Site Telephone Contact or Triggered Onsite Monitoring Visit)
● Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
● Review of the Study Central Monitoring Plan
● Adhere to the key activities outlined in the SOW as per customer requirements
Qualifications
● Other Graduate/Post Graduate in Life Sciences or related field.
● Requires minimum of 2 to 5 years of work experience with minimum of 1 year relevant experience.
● r equivalent combination of education, training and experience. Experience level may vary based on customer specific requirements.
● Good knowledge of applicable clinical research regulatory requirements.
● i.e., International Conference on Harmonisation - Good Clinical Practice and relevant local laws, regulations and guidelines.
● Proficient in Clinical Systems (good knowledge on electronic data capture (EDC), interactive X response system (IXRS), clinical trial management system (CTMS) or equivalent systems).
● Experience of managing global phase trials and clinical trial systems and/or reviewing clinical trial data.
● Strong written and verbal communication skills including good command of English language.
● Results and detail-oriented approach to work delivery and output.
● Good problem-solving skills. ● Good planning, time management and prioritization skills.
● Attention to detail and accuracy in work.
● Good software and computer skills, Microsoft Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
● Ability to establish and maintain effective working relationships with coworkers, managers and clients.
● Strong telecommunication skills.
● Good data entry skills.