[Hiring] Senior Clinical Trial Manager @Worldwide Clinical Trials

Role Description

Responsible for oversight and leading the delivery of clinical study site management activities through the coordination of a team of clinical staff on particularly complex studies (such as those that have a significant global reach). Responsible for ensuring site qualification, initiation, interim monitoring, site management, and study close-out activities for studies in accordance with the study protocol and study plan. Uses data metrics and project planning to monitor and secure quality of data submitted from study sites and timely completion, including appropriate reporting and follow-up for all safety events by site personnel.

What you will do

• Provide leadership and direction to clinical site management team members from study start through closure.
• Oversee regional CTMs and coordinate efforts across the CTM team.
• Represent Site Management issues at Sponsor, Investigator, and Bid defense meetings and act as main point of contact for activities through the study.
• Contribute to the overall project plan by formulating a global monitoring strategy for site initiation, enrollment, site management, and closeout phases across a given region and assign sites on behalf of the sponsor.
• Provide regular input to various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition, and other systems as needed.
• Collaborate closely with other functions including Business Development, Regulatory, Study Start up, and Project Management to anticipate requirements and achieve study goals.

Qualifications

• Excellent oral and written communication skills in English.
• Excellent planning and organizational skills with effective time management.
• Excellent interpersonal skills with the ability to work and influence across diverse cultures.
• Excellent presentation skills.
• Ability to lead and motivate assigned team dispersed remotely across time zones.
• Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

Requirements

• Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies, a minimum experience of four years as a Senior Clinical Research Associate (or equivalent) OR
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of six years as a Senior Clinical Research Associate.
• Minimum 2 years relevant experience as a CTM/LCRA (or equivalent) including overseeing a CTM team.
• Travel required.
• Valid current passport required.
• Driving license required.

Benefits

• Salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
• United States of America - $112,000.00 - $222,000.00.
• Compensation will fall within the provided range, and it is not a guarantee of exact salary.
• The final salary will be determined based on relevant experience, performance, education, and internal equity.
• In addition to base salary, we offer a competitive benefits package depending on location.
• We ensure pay equity and transparency and comply with all applicable labor laws.
• Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.