- 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.
- 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
- Ability to travel is required
- The salary range for this position is commensurate with experience
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Senior Clinical Trials Manager - Waltham, United States - Viridian Therapeutics
Description
At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.
The Senior Clinical Trials Manager / Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. Senior CTM / 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 our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. Remote work is allowed, and the frequency is at the discretion of management.
Responsibilities (including, but not limited to):
•C ompetitive pay and stock options for all employees
•Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
•Fertility and mental health programs
•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 mental, financial, and proactive physical health programs covered by Viridian
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.
