Provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices. The CML has particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues.
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 standard operating procedures, International Conference on Harmonisation – Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.
To provide expertise support in the Centralized monitoring studies from Applications, Analytics and Therapeutics or Quality perspective.
• Serve as an expert on centralized monitoring studies to support from Applications, Analytics, Therapeutics, Quality perspective. Provide technical inputs in developing study specific documents, plans, applications. Provide centralized monitoring support to the relevant stake holders within the project team for assigned deliverables. Assist the relevant stake holders within the project team in developing the study management plans, tools and templates and maintain the team accountabilities as applicable. Provide resolution to the internal study team on study specific issues highlighted in the study. Provides inputs to cross functional team in managing project deliverables. Provide technical support in setting up Data analytics in the study. Support the centralized monitoring services manager in periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required. Support as a Subject Level Data reviewer (SLDR) and Identify any anomalies in patient reported data by performing Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy. Oversee & perform trigger management compliance and i-site pack delivery. Provide technical support in conducting in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data). Conduct periodic review of site level key risk indicators 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. Review of the Study Central Monitoring Plan. Act as point of contact for assigned deliverables for customer or projects/specified. Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check. Mentor projects/ initiatives on industry best practices. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Establish and maintain effective project/ site level communications with relevant stakeholders. Maintain relevant project documents. Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, standard operating procedures, respective regulation and guidelines. Collaborating with peers and promoting cross functional synergies. Attend Kick-Off meetings, weekly team meetings, and client meetings, as per the project specific needs. Coordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Coaching and mentoring of Subject Matter Expert (SME).
• 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
• Can be assigned as Quality Assessor.
• Bachelor’s Degree Bachelor’s degree in clinical, life sciences, mathematical sciences, or related field, nursing qualification or allied medical degree.
• Requires minimum of 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial experience or equivalent combination of education, training and experience.
• 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, negotiating and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In depth therapeutic and protocol knowledge.
• Strong organizational, problem solving and decision-making skills.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Effective presentation skills.
• 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.
• To lead team and effectively work in team.