Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices. To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts. To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements. Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.
Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards. Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.
Develop and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study. Support project management team to develop monitoring strategy including monitoring triggers/thresholds. Manage the operational insight of the assigned project(s) 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.)
• Manage assigned studies under supervision.
• Attend study team meetings as needed or requested.
• Contribute to the development and use of study management plans and/or risk-based monitoring specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study. (CM-study/CM-subject lead)
• Support project management team to develop monitoring strategy including monitoring triggers/thresholds. (CM-study/CM-subject lead)
• Manage the operational insight of the assigned project(s) 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.)
• Contribute to developing the study specific analytics strategy and/or work on developing advanced analytics. (CM-study)
• 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. (CM-study)
• Support CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
• Collaborate with and support project resources (CRAs/ CTAs/Centralized Monitoring team).
• Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
• Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.
• Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.
• Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
• In collaboration with data owners and functional managers, contribute to development of data analysis methods and procedures for mining study data
• performing the trend analytics for their respective study(ies). (CM-Study)
• Participate in (study) team meetings/Project kick off meetings (CM-study/CM-subject lead) and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items.
• Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team.
• 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. (CM-subject)
• 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.
• 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 (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.
• Maintain relevant project documents.
• Reviews reports per annotations, SOPs, guidelines etc, identifies issues and escalates the same to the CL, prepares annotations and conducts CRA trainings, conducts monthly SRS-CL calls to discuss major issues emerging from the trends noted during report review
• 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 Harmonisation - 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 timeline 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.
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