Job Information
ICON Clinical Research Global Clinical Project Manager (MAO) - US/Canada - Home Based in Remote, Canada
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Clinical Trial Management and Central Trial Oversight services provide for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones, including country & site feasibility and site selection, trial set-up, trial execution and trial closure and vendor set up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL).
This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. Interface with stakeholders; internal and external to Global Clinical Development Operations functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GTL and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through close-out. Takes ownership for assigned responsibilities.
Demonstrated competency to act as a backup or first point of contact in absence of the Global Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non-project work
What you need to have:
BASE Level (CTM)
• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
• 6 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
• Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills.
• Effective leadership skills and ability to manage multiple stakeholders.
• Proven ability to lead a team through formation stages, up to operating as a high performing team.
• Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness.
• Experience and ability in coordinating global teams in a virtual environment for 2 - 4 years.
• Proven experience in proactive planning, risk mitigating and gaining team consensus on updated plans during the project lifecycle.
• Strong project planning/management.
• Independent complex decision making.
• Solution oriented and proactive risk identification and mitigation.
• Strong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems.
• Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring.
• Travel.
• Proficient in speaking and writing local country language and English.
• Effective verbal and written communication skills leading to successful team collaboration
• Strong decision making. Solution oriented.
• Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available.
• Experience in developing presentations and presenting key information to stakeholders.
• Ability to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.
ADVANCED Level (Sr CTM)
• 8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience. Experience and ability in coordinating global teams in a virtual environment for 6-8 years. Requirements as above.
• Ability to proactively and autonomously identify and preempt budget issues and work with key stakeholders to resolve.
**To qualify, applicants must be legally authorized to work in the United States and/or Canada, and should not require, now or in the future, sponsorship for employment visa status
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.