Heartflow
Overview
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using cutting-edge technology. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact with Heartflow Clinical Research staff and collaborate with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines and maintain high quality standards. The CTM should have demonstrated experience with clinical research study execution, exceptional organizational skills, attention to detail, and comfort working in a fast-paced start-up culture.
Job Responsibilities:
Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
Participates in and leads process improvement activities within the department and cross-functionally, including SOP development
Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
Perform other duties as required for successfully completing studies, as necessary
Skills Needed:
Ability to work in a smaller team environment with an all-hands-on-deck attitude
Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
High attention to detail, accuracy, and quality and the ability to effectively prioritize multiple projects
Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
Excellent written and oral English communication skills
Proficiency in computer programs, especially Microsoft Word, Excel, and PowerPoint
Educational Requirements & Work Experience:
Bachelor’s degree in science or health-related field
Demonstrated 5 years minimum relevant experience
Experience in cardiovascular medical device clinical research a plus
Travel required: up to 25%
A reasonable estimate of the base salary compensation range is $95,000 to $140,000 and cash bonus.
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify: A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
Note:
This description reflects the role as described and does not include any other roles listed in the posting.
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Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, using cutting-edge technology. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact with Heartflow Clinical Research staff and collaborate with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to ensure clinical studies meet or exceed timelines and maintain high quality standards. The CTM should have demonstrated experience with clinical research study execution, exceptional organizational skills, attention to detail, and comfort working in a fast-paced start-up culture.
Job Responsibilities:
Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
Participates in and leads process improvement activities within the department and cross-functionally, including SOP development
Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
Perform other duties as required for successfully completing studies, as necessary
Skills Needed:
Ability to work in a smaller team environment with an all-hands-on-deck attitude
Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
High attention to detail, accuracy, and quality and the ability to effectively prioritize multiple projects
Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
Excellent written and oral English communication skills
Proficiency in computer programs, especially Microsoft Word, Excel, and PowerPoint
Educational Requirements & Work Experience:
Bachelor’s degree in science or health-related field
Demonstrated 5 years minimum relevant experience
Experience in cardiovascular medical device clinical research a plus
Travel required: up to 25%
A reasonable estimate of the base salary compensation range is $95,000 to $140,000 and cash bonus.
Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify: A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
Note:
This description reflects the role as described and does not include any other roles listed in the posting.
#J-18808-Ljbffr