Local Trial Manager (NSI or CNS or Neuroscience experience required)

ICON Strategic Solutions; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

An established industry player is seeking a dedicated Local Trial Manager to oversee the execution of clinical trials. This fully remote role offers a competitive salary and the opportunity to work with a talented team in the pharmaceutical sector. You will be responsible for ensuring high-quality trial delivery, managing local vendors, and collaborating with internal partners to achieve study objectives. If you possess a strong background in trial management and are passionate about advancing healthcare, this is the perfect opportunity for you to make a significant impact in a dynamic environment.

Qualifications

• 2 years of local trial management experience required.
• Strong working knowledge of ICH-GCP and local regulations.

Responsibilities

• Ensure top-quality end-to-end trial delivery at a country level.
• Manage local milestones from feasibility through study close out.

Skills

Local Trial Management

Clinical Trial Management

Communication Skills

Knowledge of ICH-GCP

Problem-Solving

Education

Bachelor's Degree in Health or Science

Tools

Clinical Trial Management Software

Microsoft Office Suite

Job description

Local Trial Manager (NSI or CNS or Neuroscience experience required)

ICON is about to open 5 new Local Trial Manager positions (NSI or CNS or Neuroscience experience required)

Fully remote position with starting pay is up to $120k (No bonus)

Must currently be working for a CRO, Pharmaceutical or Biotechnology Company, have a bachelor’s degree with at least 2 years of local trial management (running the US portion of the global trials) with a title such as Clinical Trial Manager, Local Trial Manager, Study Manager. Must have experience running trials in NSI or CNS or Neuroscience.

Local Trial Manager

Responsibilities:

• The L-LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level, managing the consistency of Local Trial Management duties and processes. The L-LTM will serve as the country-level single point of contact on the study for internal partners. While the L-LTM may delegate tasks to other LTMs or roles on the study, the L-LTM remains accountable for successful completion of those tasks.
• The L-LTM will manage and oversee the following throughout the study:
• Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.
• Execution of local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).
• Inspection Readiness and AQR at the country level.
• Close collaboration with the assigned Local Trial Manager(s) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) to oversee trial excellence.
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.

Qualifications:

• Degree in a health or science related field.
• 2 years of local trial management or mutually agreed clinical trial experience.
• Specific therapeutic area experience may be required depending on the position.
• Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures.
• Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home according to business needs.
• Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
• 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.

Seniority level

Associate

Employment type

Full-time

Job function

Research

Industries

Pharmaceutical Manufacturing