Location: 3x per week in Waltham, MA
Description
The client is a biotech company that is focused on developing advanced medicines for individuals living with autoimmune and rare diseases. Using expertise in antibody discovery and engineering, they have established a pipeline of unique investigational therapeutic candidates for well-validated targets. The team comprises talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. They prioritize data-driven decisions, thoughtful risk-taking, and efficient use of resources to best position their ideas for success. The company values innovative ideas, open communication, and transparency, fostering a culture that supports high-level contribution, career growth, and a balance between personal and professional goals.
Reporting to the Director of Clinical Operations, the Clinical Trial Manager supports the Global Clinical Trial Manager in executing clinical studies on schedule and within budget. This role involves working with the study team to ensure studies are conducted efficiently and with quality, adhering to timelines and budget, and aligning with the company's strategic goals.
This position is based at their headquarters in Waltham, MA. Office-based employees follow a hybrid in-office schedule, with remote work allowed at management's discretion.
Responsibilities:
- Accountable for assigned project-related efforts for the delivery of studies critical to a product’s clinical development, supporting the Global Clinical Trial Manager to ensure 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 developing vendor oversight plans.
- Provide clinical leadership to CROs, other vendors, and CTAs.
- Assist with developing study timelines and budgets for assigned studies and be 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 impacting study or milestones.
- Provide technical advice to team members as needed.
- Disseminate clinical program communications to functional groups and support study and team meetings.
- Interact with clinical research investigators, key opinion leaders, and sites.
- Report progress of milestones to senior management.
- Support oversight of study team and site training.
- Assist with quality processes and quality assurance interactions for assigned projects.
- Manage study drug distribution and accountability processes and documentation.
- Oversee study start-up, study management, data cleaning, and study closeout activities.
- Manage 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, and informed consent forms.
- Perform other duties as assigned by the Global Clinical Trial Manager or Director of Clinical Operations.
Requirements:
- BA/BS degree in Health or Life Sciences required, advanced degree preferred.
- A minimum of 3-5 years of industry experience with at least 2 of those years in clinical trial management or equivalent experience.
- Exceptional communication and interpersonal skills.
- Positive team-oriented attitude.
- Fluent in English, if it is their second language.
- Advanced proficiency in Microsoft Office and Microsoft Project.
- Reliable, self-motivated, and a team player.
- Detail-oriented with excellent organizational skills.
- Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment.
- Creative problem solver.
- Strong commitment to ethical standards.
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
- Ability to travel as needed.
- Salary range commensurate with experience.
Benefits:
- Competitive pay and stock options for all employees.
- Comprehensive medical, dental, and vision coverage with 100% of premiums paid for employees and their eligible dependents.
- Fertility and mental health programs.
- Short- and long-term disability coverage.
- Life, travel, and AD&D insurance.
- 401(k) company match with immediate vesting.
- Employee stock purchase plan.
- Generous vacation plan and paid company holiday shutdowns.
- Various mental, financial, and proactive physical health programs.
The company provides equal employment opportunities to all employees and applicants, prohibiting 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. They ensure reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Contact them to request accommodation. They participate in E-Verify, the federal program for electronic verification of employment eligibility.
