Clinical Trial Manager

Location
South San Francisco
Posted
Jun 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

 

Well-funded Bay Area (South San Francisco) clinical stage biotechnology company is looking for an experienced Clinical Trial Manager (CTM) who will be involved in the day to day management of multiple clinical studies in rheumatic diseases and autoimmune/inflammatory disorders.

The CTM will independently lead the planning, execution and reporting of multiple Phase 1b and/or Phase 2 trials for our lead compound, KZR-616 (a selective inhibitor of the immunoproteasome). This is an exciting opportunity to play a strategic role in the research and development of novel therapies for serious diseases.

Specific job responsibilities will include:

•  Lead cross-functional teams (research/clinical/regulatory, etc) through activities dedicated to study design and execution

•  Contribute to clinical study documentation including clinical protocols, investigator’s brochure, IND updates, clinical narratives and clinical study reports

•  Participate in the selection of vendors and Investigators; proactively manage vendors

•  Manage study timelines and budget; proactively participate in aspects of financial management of the trial(s): budget setting and forecasting

•  Proactively identify project risks and manage issues to resolution

•  Maintain effective relationships with clinical collaborators and, on occasion, key opinion leaders and clinical site personnel

•  Analyze information, and utilize prior clinical experience and problem-solving skills to ensure the best possible outcome for the clinical research program

•  Position may include up to 30% domestic and/or international travel

Requirements

•  Bachelor’s degree in a scientific field or equivalent and 5+ years of Clinical Research experience

•  3+ years direct experience managing clinical studies, clinical documentation, clinical operations team interaction and clinical implementation methodology

•  Sound computer skills: proficient in the use of Excel, Word, Project and Powerpoint; experienced with EDC systems; an aptitude for being able to train rapidly on new systems and facilitate the deployment of such systems to broader audiences. Highly competent in an electronic environment and the handling of documentation in such environments

•  Ability to work with a high degree of initiative and independence while exercising appropriate judgement when direction is required

•  Thorough knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs

 Skills

•   Attention to detail

•   Ability to interact appropriately with clinical site personnel, and vendors, negotiating and motivating in a professional manner to achieve the right objectives in clinical project matters (finance, documentation or laboratory issues)

•  Strong organizational, communication (oral and written), and interpersonal skills

•  Time management, planning and project management skills

•  Thorough understanding of documentation management and document control workspaces (principles of audit trail and permissions control)

•  Multi-tasking skills and ability to manage multiple competing tasks, tracking multiple deadlines and competing activities