Project Manager
Apply NowCompany: Catalyst Clinical Research
Location: Boulder, CO 80301
Description:
Job Description
Last Modified 7 March 2015 Job Title Clinical Research Manager/Senior Clinical Research Manager Job Summary: Responsible for the execution of clinical studies to required quality standards, on schedule and on budget. Essential Job Duties and Functions: Provides administrative and clinical support to a group of investigator sponsored trials (ISTs); including maintenance of the business study files, ensuring timely site payments, study drug supply, and coordination of communication and study updates between the sponsor investigators and the company providing support for the trial. Leads, plans and executes oncology studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines Responsible for developing and implementing project plans, communication, deviation and monitoring plans Primary clinical study contact both inside and outside the organization and oversees the management of study sites and training of vendors, CRAs and clinical site staff to ensure protocol and regulatory compliance Responsible for tracking study performance data and utilitizing it to drive data based decision making for study management May assist the study team with eCRF design and generation of protocols, protocol amendments, informed consent forms and investigator brochures, and maintenance of the trial master file Provides field based oversight monitoring, site management support, and trip report review Disseminates clinical study communications to all internal functional groups and study vendors Interacts with clinical research investigators and sites May interact with Senior Management to report on progress of milestones Organizes, attends, presents and provides training at investigator meetings and site initiation visits Works with cross functional stakeholders to facilitate delivery to study plans Provides leadership to vendors, CRA team, CRMs, and CTAs Travel required: up to 20%
Experience Required
BA/BS degree Minimum 5 years experience in clinical study management and clinical trial operations Oncology therapeutic experience Line and/or matrix management experience Solid understanding of the processes and interactions essential for successful study and program management Strong project management and organization skills Strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization A strong communicator with excellent verbal and written communication skills Required Specialized or Technical Skills: In-depth knowledge of ICH/GCP guidelines, basic regulatory requirements Good technical knowledge of oncology therapeutic area Experience in supporting investigator sponsored trials preferred Experience in clinical trial management in Phase I-IV settings including study start-up, conduct and close-out Physical Requirements: The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, or crouch. Periods of time sitting at a computer may be in excess of 4 hours. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities include close vision, depth perception and ability to adjust and focus. This position also requires a normal amount of extended work hours as needed. Work Environment: The work environment characteristics are those an employee encounters while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee is occasionally exposed to work environment with various pieces of office equipment. The noise level in the work environment is usually moderate to low. The employee may be exposed to weather and temperature extremes.
Last Modified 7 March 2015 Job Title Clinical Research Manager/Senior Clinical Research Manager Job Summary: Responsible for the execution of clinical studies to required quality standards, on schedule and on budget. Essential Job Duties and Functions: Provides administrative and clinical support to a group of investigator sponsored trials (ISTs); including maintenance of the business study files, ensuring timely site payments, study drug supply, and coordination of communication and study updates between the sponsor investigators and the company providing support for the trial. Leads, plans and executes oncology studies to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines Responsible for developing and implementing project plans, communication, deviation and monitoring plans Primary clinical study contact both inside and outside the organization and oversees the management of study sites and training of vendors, CRAs and clinical site staff to ensure protocol and regulatory compliance Responsible for tracking study performance data and utilitizing it to drive data based decision making for study management May assist the study team with eCRF design and generation of protocols, protocol amendments, informed consent forms and investigator brochures, and maintenance of the trial master file Provides field based oversight monitoring, site management support, and trip report review Disseminates clinical study communications to all internal functional groups and study vendors Interacts with clinical research investigators and sites May interact with Senior Management to report on progress of milestones Organizes, attends, presents and provides training at investigator meetings and site initiation visits Works with cross functional stakeholders to facilitate delivery to study plans Provides leadership to vendors, CRA team, CRMs, and CTAs Travel required: up to 20%
Experience Required
BA/BS degree Minimum 5 years experience in clinical study management and clinical trial operations Oncology therapeutic experience Line and/or matrix management experience Solid understanding of the processes and interactions essential for successful study and program management Strong project management and organization skills Strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization A strong communicator with excellent verbal and written communication skills Required Specialized or Technical Skills: In-depth knowledge of ICH/GCP guidelines, basic regulatory requirements Good technical knowledge of oncology therapeutic area Experience in supporting investigator sponsored trials preferred Experience in clinical trial management in Phase I-IV settings including study start-up, conduct and close-out Physical Requirements: The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle or feel, reach with hands and arms, climb or balance, stoop, kneel, or crouch. Periods of time sitting at a computer may be in excess of 4 hours. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities include close vision, depth perception and ability to adjust and focus. This position also requires a normal amount of extended work hours as needed. Work Environment: The work environment characteristics are those an employee encounters while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee is occasionally exposed to work environment with various pieces of office equipment. The noise level in the work environment is usually moderate to low. The employee may be exposed to weather and temperature extremes.