Clinical Trial Manager
Viridian Therapeutics, Inc., Waltham, MA, United States
At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases, and we are getting closer to achieving this goal every day.
Reporting to the Director, Clinical Operations, the Clinical Trial Manager is responsible for supporting the Global Clinical Trial Manager in the execution of clinical studies on schedule and on budget. The Clinical Trial Manager works with the study team to ensure studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company’s strategic goals.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
Accountable for assigned project related efforts for the delivery of studies that are critical to a product’s clinical development, supporting the Global Clinical Trial Manager Study Lead to ensure that studies are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
Support the external vendor management process and assist in the development of vendor oversight plans
Provide clinical leadership to CROs, other vendors, and Clinical Trial Associates (CTAs)
Assist with the development of study timelines and budgets for assigned studies and is accountable for delivery to both quality and agreed timelines
Support project leadership of the cross-functional study team, including external team members, CROs and vendors
Plan, negotiate, and manage site budgets as well as assist with facilitating the site contracting process
Support development and implementation of robust contingency and issue management plans to solve complex issues that impact study or milestones
Provide technical advice to team members
Disseminate clinical program communications to functional groups and support study and team meetings
Interact with clinical research investigators, Key Opinion Leaders and sites
Interact with Senior Management to report on progress of milestones
Support oversight of study team and site training
Assist with Quality processes and Quality Assurance interactions for assigned project(s)
Support management of study drug distribution and accountability processes and documentation
Support oversight of study start-up, study management, data cleaning, and study closeout activities
Assist with final study files and documentation, including TMF, final TLFs, and final study data archival
Support the development and writing of study protocols, study plans, CRFs, informed consent forms
Other duties as assigned by the Global Clinical Trial Manager or Director, Clinical Operations
Qualifications:
BA/BS degree in Health or Life Sciences required (advanced degree preferred) with 4+ years of industry experience with at least 2 of those years in clinical trial management 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 in a fast-paced environment
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel as needed
The salary range for this position is commensurate with experience
Benefits:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
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Reporting to the Director, Clinical Operations, the Clinical Trial Manager is responsible for supporting the Global Clinical Trial Manager in the execution of clinical studies on schedule and on budget. The Clinical Trial Manager works with the study team to ensure studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company’s strategic goals.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):
Accountable for assigned project related efforts for the delivery of studies that are critical to a product’s clinical development, supporting the Global Clinical Trial Manager Study Lead to ensure that studies are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines
Support the external vendor management process and assist in the development of vendor oversight plans
Provide clinical leadership to CROs, other vendors, and Clinical Trial Associates (CTAs)
Assist with the development of study timelines and budgets for assigned studies and is accountable for delivery to both quality and agreed timelines
Support project leadership of the cross-functional study team, including external team members, CROs and vendors
Plan, negotiate, and manage site budgets as well as assist with facilitating the site contracting process
Support development and implementation of robust contingency and issue management plans to solve complex issues that impact study or milestones
Provide technical advice to team members
Disseminate clinical program communications to functional groups and support study and team meetings
Interact with clinical research investigators, Key Opinion Leaders and sites
Interact with Senior Management to report on progress of milestones
Support oversight of study team and site training
Assist with Quality processes and Quality Assurance interactions for assigned project(s)
Support management of study drug distribution and accountability processes and documentation
Support oversight of study start-up, study management, data cleaning, and study closeout activities
Assist with final study files and documentation, including TMF, final TLFs, and final study data archival
Support the development and writing of study protocols, study plans, CRFs, informed consent forms
Other duties as assigned by the Global Clinical Trial Manager or Director, Clinical Operations
Qualifications:
BA/BS degree in Health or Life Sciences required (advanced degree preferred) with 4+ years of industry experience with at least 2 of those years in clinical trial management 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 in a fast-paced environment
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel as needed
The salary range for this position is commensurate with experience
Benefits:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.
#J-18808-Ljbffr