Clinical Trial Manager at Clinical Dynamix, Inc.
Waltham, MA
About the Job
The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget
CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
This role is based in their Waltham, MA headquarters
Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham 3 days per week)
Responsibilities
Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
May provide technical advice to team members.
Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
Interact with clinical research investigators, Key Opinion Leaders and sites.
Interact with Senior Management to report on progress of milestones.
Oversight of study team and site training
Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
Management of study drug distribution and accountability processes and documentation
Oversight of study start-up, study management, data cleaning, and study closeout activities
Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
BA/BS degree in Health or Life Sciences required, advanced degree preferred
A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Exceptional communication and interpersonal skills
Positive team orientated attitude
Must speak fluent English if it is their second language
Advanced proficiency in Microsoft Office and Microsoft Project
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities
Creative problem solver
CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs.
This role is based in their Waltham, MA headquarters
Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham 3 days per week)
Responsibilities
Accountable for project related efforts for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
Supports external vendor selection and management process and assists in the development of RFP’s and vendor oversight plans.
Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
Project leadership of the cross-functional study team, including external team members, CROs and vendors.
Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
May provide technical advice to team members.
Disseminate clinical program communications to all functional groups and leads program, study and team meetings.
Interact with clinical research investigators, Key Opinion Leaders and sites.
Interact with Senior Management to report on progress of milestones.
Oversight of study team and site training
Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
Management of study drug distribution and accountability processes and documentation
Oversight of study start-up, study management, data cleaning, and study closeout activities
Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.
Requirements
BA/BS degree in Health or Life Sciences required, advanced degree preferred
A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
Exceptional communication and interpersonal skills
Positive team orientated attitude
Must speak fluent English if it is their second language
Advanced proficiency in Microsoft Office and Microsoft Project
Reliable, self-motivated, team player
Detail oriented with excellent organizational skills
Ability to effectively manage multiple tasks and competing priorities
Creative problem solver
