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DOCS Sr. Clinical Trial Manager in Helena, Montana

Sr. Clinical Trial Manager

Ref #: 31426

Employment type: Permanent - Full-Time

Location: United States

Posted: 01-Nov-2021

Description

Job Summary:

Provides local management of a clinical trial (or Medical Affairs data

generation activity) in the US. Responsibiities/deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities. Further, will ensure the local trial team is delivering quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference of Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA),Site Manager (SM) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study

delivery at the country level.

Job Description:

• Sr. LTM is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM.

• Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.

• Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.

• Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.

• Uses study tools and management reports available to analyze trial progress.

• Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.

• Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.

• Adheres to finance reporting deliverables and reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed

• May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.

• Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs.

Qualifications:

• A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.

• Minimum six years of pharmaceutical and/or clinical trial experience is preferred. Minimum of 2 years of clinical trial management experience for a pharmaceutical/CRO.

• Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.

• Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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, color, 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.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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