Sr. Clinical Trial Manager - San Francisco, CA | Biospace
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Sr. Clinical Trial Manager

Lab Support, A Division Of On Assignment

Location:
San Francisco, CA
Posted Date:
10/28/2016
Position Type:
Full time
Job Code:
Salary:
140k
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Pharmaceutical,

Job Description

Position Summary:
The Clinical Trial Manager is a critical position. In close collaboration with the VP Clinical Operations & Regulatory Affairs, the CTM will be responsible for the operational management of the company's clinical trials.The CTM will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget.



Responsibilities:

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities
Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
Conduct study monitoring visits and co-monitoring visits as needed
Provide regular updates of study progression to Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
Lead feasibility assessment and selection of countries and sites for study conduct
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
Provide oversight and direction to study team members, including vendors, for study deliverables
Coordinate with finance to track the financial status against budget

Requirements

   
Clinical Trial Manager

Position Summary:
The Clinical Trial Manager is a critical position. In close collaboration with the VP Clinical Operations & Regulatory Affairs, the CTM will be responsible for the operational management of the company's clinical trials.The CTM will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and within budget.



Responsibilities:

Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, regulatory affairs) in order to accurately coordinate clinical study activities
Coordinate clinical study timelines with Project management to meet critical milestones; escalate issues that may jeopardize timelines and deliverables
Conduct study monitoring visits and co-monitoring visits as needed
Provide regular updates of study progression to Clinical Development Lead, Program Management, and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables
Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance
Lead preparation of vendor requirements and project scope and selection of study vendors; effectively manage interactions with vendor study team
Lead feasibility assessment and selection of countries and sites for study conduct
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals)
Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members
Provide oversight and direction to study team members, including vendors, for study deliverables
Coordinate with finance to track the financial status against budget


Minimum Requirements:

BA/BS degree with at least 8 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 5 years clinical trial experience
Must have strong knowledge of ICH/GCP guidelines
Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
Strong experience in management of CROs and other vendors
Requires proven project management skills and study leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
Ability to “roll up your sleeves” and individually contribute results to a research and development effort
Ability to travel up to 25%