Senior Clinical Trial Manager (US)

Worldwide Clinical Trials•Carolina, NC

1d•$112,000 - $222,000•Remote

About The Position

Responsible for oversight and leading the delivery of clinical study site management activities through the co-ordination 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 with 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.

Requirements

Excellent oral and written communication skills in English
Excellent planning and organizational skills with effective time management
Excellent interpersonal skills with 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
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

Responsibilities

Provide leadership and direction to clinical site management team members from study start through closure
Oversee regional CTMs and coordinates 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
Contributes 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 assigns 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
Collaborates closely with other functions including Business Development, Regulatory, Study Start up and Project Management to anticipate requirements and achieve study goals