Essential Functions
● Manage assigned sites and perform Subject Level Data Review independently, if required perform with both responsibilities as dual role.;
● Perform remote monitoring visits for assigned sites as assigned.;
● 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. Contribute in developing new analytics proposal as per customer's demand, Ability to write analytical inferences to add business value.;
● 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.).;
● With guidance, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections.;
● Identify the value adds from the centralized review & remote monitoring in the study and provide the inputs to relevant stakeholders.;
● Support CMS leads to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.;
● Collaborate and support project resources (CRAs/ CTAs/Centralized Monitoring team).;
● Ensure complete and accurate documentation of all the site-specific tools and templates and keep the sites audit ready.;
● Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;
● Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the Site-specific information.;
● Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).;
● Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team.;
● Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risk/issue(s).;
● Monitor site performance and make recommendations for timely corrective actions (e.g. 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.;
● Work in accordance of the Study Central Monitoring Plan.;
● Establish and maintain effective project/ site level communications with relevant stakeholders.;
● Provide Mentorship to Associate Central Monitors.;
● Reviews reports per annotations, SOPs, guidelines etc., identifies issues and escalates the same to the Clinical Lead, prepares annotations and conducts CRA trainings, conducts monthly calls with relevant stakeholders to discuss major issues emerging from the trends noted during report review.;
● Act as a technical solution specialist (TSS) point of contact to connect with the project teams/internal stake holders for gathering the criteria and requirements.;
● Analyze the complexity of the requirements and provide the EAC hours and turn around time.;
● Review of the Study Central Monitoring Plan
● Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
● Adhere to the key activities outlined in the SOW as per customer requirements.
Qualifications
● Bachelor's Degree Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, or nursing qualification.
● Requires minimum of 2 years of relevant work experience or equivalent combination of education, training and experience.
● Fresher with Medical or Allied medical degree.
● Experience in clinical research field preferred.
● Experience level may vary based on customer specific requirements.
● Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements.
● i.e. International Conference on Harmonization - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
● Good Clinical system expertise.
● Strong written and verbal communication skills including good command of English language.
● Results and detail-oriented approach to work delivery and output.
● Understanding of clinical/medical data.
● Good motivational, influencing, coaching skills.
● Ability to work on multiple projects and manage competing priorities. In depth therapeutic and protocol knowledge.
● Strong organizational and problem-solving skills.
● Effective presentation skills.
● Demonstrated ability to deliver results to the appropriate quality and time line metrics.
● Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.