Clinical Trial Manager

As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Role Summary

• Primary point of contact for the management and coordination of the conduct of clinical trials from study start-up to close out at  country level in accordance with ICH-GCP and local regulations.
• Planning and oversight of clinical study execution in accordance with the global program strategy, through leadership of the Local Study Team.
• Collaboration with all stakeholders to ensure that trial deliverables are met within the country.
• Partnering closely with the local and global teams to ensure that the strategic goals and study program goals are met.
• Ensure that quality and integrity of all trials are monitored at country level, through strong site relationships, protocol and expert knowledge of the clinical trial process.

Responsibilities

• Recognize potential challenge within the protocol and operational aspects of the trial and escalate to manager as appropriate.
• Maintain a strong knowledge of the protocol to be able to answer standard operational questions from monitors, sites, and local internal personnel.
• In liaison with the global clinical team, assist in the development of local trial execution plan and timeline commitments for a country/cluster.
• Ensure that study start-up activities and any amendments are conducted and completed on time, including preparation of IRB/EC submission packages, working with regulatory affairs for Health Authorities submissions.
• Monitor the status of site budget and contract negotiations as well as the collection and review of essential documents.
• Ensure sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.
• Ensure that all documentation in place for initial and subsequent drug release in collaboration with the local Qualified Person.
• Provide training as needed for monitors and any other activities that support site readiness to recruit.
• Ensure documentation of training (global/regional/local IM minutes, participants’ lists, certificates, etc.) is archived appropriately.
• Drive the conduct of the trial, track and oversee progress and status.
• Ensure all operational aspects are on schedule.
• Oversee local clinical team activities to achieve trial timelines and quality execution according to standards and local and international regulations.
• Consistently read/review the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.
• Communicate with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics.
• Lead and chair local study team meetings, attend and participate in global clinical trial team meetings.
• Track trial budget with appropriate trial budget responsible in country. Oversee TCF preparation and submission to COM in collaboration with the TCF specialist in the country.
• Keep oversight of country level data management activities, including timely resolution of data entry issues, screen failure reasons, discontinuation rates, patient profiles, and proactively identify data entry issues to mitigate queries.
• Accountable to keep reporting systems up to date: ClinAdmin, TMF, CREDI... throughout trial conduct
• Ensure that all trial closeout activities are performed, in close cooperation with field monitors and clinical trial head.
• Oversee local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
• Facilitate internal audits and HA inspections as required.
• Support trial feasibility and CPO patient commitments in cooperation with the relevant line units: ensure two-way feedback on feasibility between global team and country.
• Coordinate and manage the site selection process in collaboration with the necessary line units
  Conduct local investigator meetings as needed.

Job requirements

• Relevant Bachelor’s degree with 5 years of related experience
• Project and Program management experience including oversight of study deliverable, budgets and timelines
• Minimum 2 years’ clinical trial project management experience in Sub-Saharan Africa region
• Minimum 7 years’ work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors
• Must be a country expert with identifiable project management experience locally

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.

#LI-Hybrid