- Expiry Date: 07 August 2021
The Senior Clinical Trial Manager role (Sr. CTM) is a developing leadership role integral to driving project success within the Clinical Operations function. This position is an in-house role focused on independently managing and overseeing clinical trial sites and clinical trial activities. As a member of the cross functional study team, the Sr. CTM directly manages site performance in line with study level plans. The position is also responsible for reviewing site visit reports, vendor management and partnering with Contract Research Organizations (CRO).
Essential duties and responsibilities:
Scope of studies
One or more, increased complexity of study and number of vendors
Study level planning and oversight
Manage all day-to-day operations
Monitor & site oversight by trip report review, identifying trends, gaps, on-going actions, deviations, etc.
Feasibility, recommends US sites & countries
Develops monitor training
Manage drug supply
Conduct clinical data review
Oversee tracking of clinical samples
Responsible for planning and presenting at Investigator Meetings
Ensure local and global healthcare compliance policies are followed
Assess risk and develop mitigation strategies with minimal oversight
Participate in vendor selection, oversee complex vendors and some aspects of CRO, review invoices prior to study lead approval
Has understanding of all vendors needed for trial, can support aspects of more complex vendors
Oversee monitoring activities, perform oversight monitor per plans, create and implement training for monitors
Oversee site payments
Assess KPIs, generate reports and proposes risk mitigation as needed
Responsible for management of lab samples
Participate in data review and query resolution
Builds strong rapport and relationships with site staff and Investigators
Relationship and stakeholder management
Developed communicator, builds & maintains strong relationships internally and externally
Review and approve global templates & site level documents for IRB/regulatory submission
Negotiating and influencing
Listens, seeks common ground and establishes credibility
Coaching and mentoring
Provides guidance and coaching as need to new Clinical Trial Manager and Clinical Trial Associate role
Business and therapeutic knowledge
Solid understanding of Clinical Operations, study phases and types
Understands the protocol, science/biology, e.g. cardiology, mechanism of action of drug
Responsible for timely submission of documents to Trial Master File, periodic reviews of TMF for quality
Ability to travel
Up to 25%
Bachelor’s degree, preferably in areas such as biological sciences, health care management or life sciences research.
Ideal candidate has at least 2-3 years of prior relevant industry experience (Clinical Trial Associate or field monitor) or experience in a clinical setting such as RN or related role
Highly proficient in software applications such as Word, Excel, and PowerPoint
Good written and verbal communication skills and proven ability to multitask. Efficient time management and organizational skills. Attention to detail and accuracy in work.
Has a basic understanding of the drug development process and knowledge of FDA regulations and guidelines.
Organizes and prioritizes numerous tasks and completes them under time constraints.
Applies technical standards, principles, theories, concepts and techniques.
Demonstrated success in problem solving.
Applies strong analytical and business communication skills.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Ability to constructively interact directly with clinical site personnel
Develops relationships with senior internal and external personnel in area of expertise.
Work is on projects that are complex due to high number of vendors requiring close oversight and management
Performs job duties with minimal guidance from supervisor
Works in dynamic environment across cultures, community and academic settings
Passion for science
Imagine and innovate
About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.