Centralized Clinical Trial Manager

Centralized Clinical Trial Manager<br><p>ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.</p><br><p>As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.</p><br><p>We are currently seeking a Centralized Clinical Trial Manager to join our diverse and dynamic team. <span>As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in effectively reviewing site visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate. You will be responsible for follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues. You will act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval''. </span></p><p></p><p>Location: Bangalore or Chennai ( Home Based or Office Based)</p><p></p><p><b>What You Will Be Doing:</b></p><p></p><ul><li>To effectively review visit reports as per Protocol and ICON and Sponsor SOPs and to ensure the quality of reports are of the highest standards , errors are minimized and that issues are escalated as appropriate</li><li>To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues.</li><li>To act as an extension of the CTM/CTM team for the specific purpose of visit report review and approval.</li><li>To observe and escalate safety trends in patients as identified in visit report</li><li>Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance .</li><li>As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.</li><li>Effectively review and approve visit reports as per annotated report, protocol, ICON and/or Sponsor SOPs and ensure errors are minimized , reports are consistent across visits and sites and adhere to the highest standards of quality . Ensure turnaround time of the visit reports per contract, ICON and or Sponsor SOPs</li><li>Regular oversight of OMR , ICO trial (and where required Sponsor CTMS and vendor systems) to ensure key metrics, e.g. MVR and FUL timelines, Action Items and other quality metrics are being met and followed-up as necessary Ensure open action items and protocol deviations are escalated and followed up for timely resolution as per contract or corporate standards .</li><li>Where required , attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends •</li><li>Liaise with CTM to communicate any trends , outstanding issues, safety concerns or any other activity or lack thereof which may jeopardise the clinical trial delivery or patient safety .</li><li>Ensure all necessary trainings , required to improve job performance managing people and project or process related issues which are necessary to perform successfully in a service oriented environment.</li><li>Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials. • Fluent in written and spoken English.</li><li>Computer literate.</li><li>Ability and willingness to travel if required</li><li>Extensive use of telephone expected continuous improvement in trial processes.</li></ul><p></p><p><b>Your Profile:</b></p><ul><li>Bachelor’s degree in life sciences, healthcare, or a related field (advanced degree preferred).</li><li>Minimum 8-10 years of Clinical Research experience with at-least 5 years of on-site monitoring experience.</li><li>Experience in On-Site Monitoring and Clinical Trial Management, with a solid understanding of on-site monitoring approaches.</li><li>Strong analytical skills with proficiency in clinical trial data review and interpretation.</li><li>Excellent organizational and project management skills, with the ability to manage multiple studies and meet deadlines.</li><li>Effective communication and interpersonal skills, with the ability to collaborate across diverse teams and functions.</li></ul><p></p><br><p>Employment with ICON is contingent upon having the legal right to work in the country where the role is based.</p><br><p><b>Rewards & Benefits</b></p><p>ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.</p><br><p>Benefits may include:</p><ul><li>Competitive base salary and performance related incentives</li><li>Health and wellbeing programmes including medical, dental, and vision coverage where applicable</li><li>Retirement and pension plans</li><li>Life assurance and disability coverage</li><li>Employee assistance programmes and wellbeing resources</li><li>Learning and development opportunities through structured training and career pathways</li></ul><br><p>Benefits may vary depending on role and location.</p><br><p>Visit our <a href="https://careers.iconplc.com/benefits" target="_blank" rel="noopener noreferrer">careers site</a> to read more about the benefits ICON offers.</p><br><p><b>Inclusion and Accessibility</b></p><p>ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.</p><br><p>If you require reasonable accommodations during the recruitment process, please let us know or submit a request <a href="https://careers.iconplc.com/reasonable-accommodations" target="_blank" rel="noopener noreferrer"><span style="color:#0875e1"><b><u>here</u></b></span></a>.</p><p style="text-align:inherit"></p><p style="text-align:left"><span>Are you a current ICON Employee? Please click </span><a href="https://wd3.myworkday.com/icon/d/task/1422$1235.htmld" target="_blank" rel="noopener noreferrer">here</a><span> to apply</span></p>

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