Clinical Study Manager (CSM) - Sponsor Dedicated - Sub-Saharan Africa
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center 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.Responsibilities
- Recognize challenges within the study and operational aspects of the trial and escalate to manager as appropriate.
- Maintain a strong knowledge of the study 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 Novartis 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 study, 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.
- 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 for keeping technical reporting systems up to date 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.
- Serve as main contact for any significant compliance issues and escalate to clinical trial team as required.
- Facilitate internal audits and inspections as required.
A minimum of 4 years’ experience is required in clinical research in a role, including project management and monitoring of clinical trials within the Sub Saharan Africa region.
- 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.