Clinical Trial Manager II

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What you will be doing:

• Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
• Lead Local Study Team(s) consisting of monitors and study administrator(s).
• Lead and optimise the performance of the local Study Team(s) at country level ensuring compliance with company Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
• Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
• Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
• Perform any required co-monitoring & QC visits with study monitor(s)
• Proactively identify and facilitate resolution of complex study problems and issues.
• Organise regular Local Study Team meetings on an agenda driven basis.
• Actively work towards achieving good personal relationships with all Local Study Team members.
• Report study progress/update to the SMO Study Leader/Team.
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
• Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
• Plan and lead national Investigator meetings, in line with local codes
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
• Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
• Ensure timely preparation of country SMA, fSMA and Master CSA.
• Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
• Ensure local Serious Adverse Event (SAE) reconciliation takes place.
• Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
• Ensure timely submission of proper application/documents to EC/IRB.
• Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
• Set up and maintain the study in IMPACT at study country level.
• Ensure accurate payments related to the study are performed.
• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and company Procedural Documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
• Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
• Provide input to process development and improvement.
• Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
• Update SMM Director/CRM about the performance of the monitors/CRAs.
• Ensure that study activities at country level comply with local policies & code of conduct.

#LI-SO1

You are:

Functional Capabilities

• Excellent knowledge of international guidelines (ICH/GCP) and relevant local regulations.
• Good understanding of the Drug Development Process.
• Excellent understanding of the Clinical Study Process (Monitoring, Study drug handling process, Data management process).
• Based in Bangalore

Essential Qualification

• Bachelor’s degree
• +2 years Clinical Trial Management experience in global CRO/Pharma
• +5 yrs onsite clinical monitoring experience
• Must be amenable to work in office-based setup in Bangalore

Desired skills or requirements

• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know