Senior Global Clinical Project Manager-US or Canada Remote-East Coast

Overview

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

Responsibilities

What will you be doing?

Joining a well-established yet expanding team fully outsourced to one of our global pharmaceutical clients, the Clinical Trial Manager ensures overall successful execution of phase 1-4 clinical trials in multiple therapeutic areas, in accordance with applicable Standard Operating Procedures, agreed timelines, budgetary and regulatory requirements, at a global scale.

The Clinical Trial Manager serves as the leader for the Study Management Team, with ultimate responsibility for the set-up, planning and coordination of clinical trials through to study closure.

Managing and tracking key study metrics to ensure adherence to project milestones, along with communicating with other departments, will form a key part of this role.

Reporting to a Clinical Program Leader, you will ensure accurate budget management, including guaranteeing that third-party vendors are working to defined plans.

Other fundamental tasks include driving activity to ensure that enrolment commitments are met, whilst also checking that relevant documentation is duly updated, resolving problems, proactively managing risk and (where necessary) timely escalating issues.

Clearly, the Clinical Trial Manager will also work in accordance with applicable health authority regulations and internal standard operating procedures.

Where necessary, participation in the preparation for and conduct of Health Authority inspections and internal audits will also feature in this role.

Working at the very heart of the clinical trial, you will deliver appropriate training to your study team on a trial-specific basis.

Additionally, you will act as a key liaison with Quality Management in order to establish a high level of quality throughout the project lifecycle.

Qualifications

The successful candidate will be an expert study manager, will have a proven record of successful execution of clinical trials on a global study.

You will be able to work to key metrics and motivate a regionally-based study team throughout the project lifecycle. Your experience in the set-up and management of third-party vendors, as well as global study start up, will be self-evident.

Familiarity with Phase I-IV studies would be highly advantageous. Demonstrable knowledge of effective project planning, strong financial acumen, along with the flexibility to manage a virtual team will ensure success within this position.

• BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
• Previous experience of working with multiple therapeutic areas, including oncology, cardiology / metabolism, infectious disease, immunology and / or vaccines is preferred.
• 6 - 8 years clinical trial management experience in the pharmaceutical industry or CRO.
• Proven track record in successfully managing various aspects of trials from Start-Up to Database Lock and Trial Closure (End to End study experience).
• 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 a minimum of 3 years.
• Willing to travel up to 20%
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Position is remote from home

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.

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