Clinical Trial Manager
Strand Therapeutics is an early-stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies.
Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. This collaboration led them to build their own mRNA “programming language,” creating the world’s first platform for mRNA smart therapies.
The founders and scientific advisors of Strand Therapeutics are made up of well-known and highly regarded individuals in both academia and the biotech industry. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts with an additional site based in Watertown, Massachusetts.
Become the next standout single strand!
Strand is looking to build a team that understands the value of working at a start-up. Joining the company now means having vast opportunities to learn and grow including having the exposure to all aspects of building a company. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small team. This opportunity will offer the employee the ability to work closely with the founding team, as well as to form close partnerships with team members during the development and formation of the company.
The Clinical Trial Manager supports Strand’s Clinical Operations team in the overall management of GCP vendors and FIH trial. This includes vendor and site oversight, system builds and UAT, clinical metrics tracking and reporting, and coordination of various activities in a fast-paced, start-up environment.
- Act as Clinical Operations Study Lead (internal and/or external) on one or more Strand clinical trials
- Manage and oversee Clinical Operations vendors and vendor activities as they relate to Strand clinical trials
- Develop study-specific plans and manage the document review/revision process
- Create, update and distribute Clinical Operations metrics
- Collaborate with Clinical Supply Chain in investigational product accountability and inventory as measured against enrollment rates
- Collaborate with Translational Biology in biological sample kit inventory, sample tracking, and accountability
- Review and routing of contracts/agreements related to Clinical Operations vendors
- Review of vendor budgets against incoming invoices and reporting discrepancies or questions to internal clinical study leads
- Facilitate RFI/RFP for potential clinical study vendors
- Schedule activities and meetings, including compilation and management of Clinical Operations materials and presentations
- Take and distribute meeting minutes for both internal and external meetings, as well as review of CRO minutes for accuracy
- Review, submit, and perform audit activities of files within the Trial Master File, for Clinical Operations-related documentation
- Communicate with and train site staff including study coordinators and clinical research physicians
- Problem-solve and suggest areas for improvement of clinical research sites’ patient recruitment and retention success, as needed
- Support other clinical study leads (internal and/or external) on one or more clinical trials
- Prepare reports and/or responses to requests from the Strand Executive Leadership Team (ELT), as required
- Support and/or design Clinical Operations departmental initiatives and process improvements
- Minimal travel required (10% both international and domestic)
- Other duties and responsibilities as required
- Bachelor’s level education, or equivalent level of experience preferred
- 10+ years of experience within one or more functional role(s) in R&D drug development, biotechnology, or related industry preferred
- Understanding of the end-to-end processes in drug development
- Excellent written and verbal skills, strong influencing and interpersonal skills
- Excellent attention to detail, ability to manage competing priorities and maintain start-to-finish cross-functional review
- Proven track record of planning and managing complex tasks in different phases of development including cross-functional deliverables across Research, Operations, and CMC
- Proficiency in MS Office software including: Word, Excel, SmartSheet, Outlook, Visio, and PowerPoint
Strand offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package (health, dental, life, vacation, 401k, and commuter) and work/ life integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet the company goals.
Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.
Job Type: Full-time
Salary: Commensurate with role and experience