Clinical Trial Manager

As a Local Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Local Trial Management services, provides local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assignedprotocol(s) at the country level from start-up through to database lock and closeout activities. Further, serviceswill ensure the local trial team is delivering quality data and trial documents/records that are compliant withthe assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conferenceon Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the ClinicalTrial Assistant (CTA)/lnvestigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager(CTM)/Global Trial Manager to ensure overall study delivery at the country level.

Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, codes of GoodClinical Practice (GCP), local regulatory requirements, etc.Complies with relevant training requirements.Contribute to quality Site Selection through participation in site feasibility ensuring consistent conductof pre-trial assessment visits and appropriate follow-up of pre-trial visit report and country feasibilityreport. Collaborates with central study team for final selection of sites to participate in trial.Ensures local/country team is meeting recruitment targets with high quality data on time and withinstudy budget by providing input to study level documents and leading/coordinating local teamactivities in compliance with SOPs, other procedural documents and applicable regulations. This mayrequire development of local trial specific procedures and tools, recruitment planning, contingencyand risk management, and budget forecasting.Act as primary company contact for assigned trial at the country level, may attend/participate inInvestigator Meetings as needed. May schedule and conduct a local/country investigator meeting.Drive study compliance by maintaining and updating trial management systems, using study tools andmanagement reports available to analyze trial progress. When necessary initiates corrective andpreventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.Contribute to site level recruitment strategy and contingency planning and implementation inpartnership with other functional areas to achieve clinical research target.Delivers competent vendor management at the country level to support the study and may submitrequests for vendor services and support vendor selection. This includes reviewing and approving siteand local vendor invoices as required. As required, manages the local study supply.Ensures high standards for study monitoring by conducting quality local trial team meetings andfacilitating SM training, when needed (i.e. implementation of study amendment-and changes in studyrelated processes). Contributes to patient understanding of protocol and patient safety by preparing country specificinformed consent in accordance with procedural document/templates. This includes reviewing andmanaging site specific informed consent forms in accordance with SOPs, other procedural documentsand applicable regulations. Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reportingtimelines and documented, as appropriate. Ensures Inspection readiness by maintaining complete, accurate and timely data and essentialdocuments in systems utilized for trial management (e.g. CTMS and eTMF/IF) according toexpectations (metrics) and archiving retention requirements. When issues are identified or trendsacross a project are noted from MVR review, will escalate deviation issues to CTM/GTL and FM intimely manner. Keeps oneself inspection ready and knowledgeable for current work by complying with relevanttraining requirements and developing therapeutic knowledge enough for role and responsibilities. With focus on quality, will work closely with SM to ensure CAPA is implemented for audits/inspectionsor any quality related visits. May conduct accompanied site visits with SM, if delegated by FM. Ensure accurate finance reporting and trial delivered within budget by adhering to finance reportingdeliverables and timelines. This includes forecasting and proactive management of country/local trialbudget. If applicable, may assist in negotiation of trial site contracts and budgets. Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HAapprovals, if applicable. May contribute as a mentor, champion, or representative of functional area in process initiatives, asrequired. Full utilization by timely and accurate time reporting.Experience in management and startup of complex Early Phase trials projection with internal matrixclinical teams and sites, as applicable.If applicable, region specific deliverables will be specified.

Education and Experience Requirements: • BA/BS degree.• Degree in a health or science related field.• 2 years of local trial management experience.

Specific therapeutic area experience may be required depending on the position.Strong working knowledge of ICH-GCP, company standard operating procedures, local laws andregulations, assigned protocols and associated protocol specific procedures.Strong IT skills in appropriate software and company systems. Willingness to travel with occasionalovernight stay away from home according to business needs.Proficient in speaking and writing the country language and English. Good written and oralcommunication skills as appropriate.

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Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.