Clinical Trial Manager, Clinical Operations
Location: South San Francisco, CA
Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti-fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.
Role: Clinical Trial Manager, Clinical Operations
The Clinical Trial Manager (CTM) will work with the Clinical Operations Team to implement and maintain clinical trials in phases I-IV, as applicable. The CTM will be responsible for adhering to all Blade and/or vendor Standard Operating Procedures (SOPs), in addition to ICH GCP and any applicable, regional/global regulatory authority procedures. This is an in-house role, based out of South San Francisco, CA. The CTM will have the benefit of working with a tight-knit team to drive projects and meet deliverables. In addition to working within the Clinical Operations team, the CTM will also be responsible for significant cross-functional interaction.
- Collaborate cross-functionally to coordinate all aspects of a clinical study.
- Develop and review study-specific documents, including plans, informed consent forms, protocols, manuals, and other study tools.
- Review and manage study financials, including budgets, invoicing, and payments for all vendors and sites.
- Coordinate with the project team to design both content and format of CRFs, patient documents, reference documents, and forms.
- Mentoring and delegation skills to guide junior team members through monitoring and tracking day-to-day operational deliverables. Desire to provide guidance is a must.
- Review line listings, write and resolve queries, review protocol deviations, and prepare for interim/final Clinical Study Reports.
- Assist in protocol development activities.
- Train new team members, including external vendor teams and sites. This may include both formal and informal trainings, such as speaking during Investigator Meetings and attending and participating in Site Initiation and Monitoring Visits.
- Review site-specific documents, including ICFs, essential documents, and site questions.
- Assist in the review of regulatory submissions or responses to requests for additional information.
- Ability to assist in clinical supply management.
- Maintain all files and lead TMF review.
- Manage monitoring activities, including possible review of monitoring reports and conducting co-monitoring visits.
- Creation and distribution of meeting agendas and minutes.
- Assist in company SOP development.
- Negotiate contracts, budgets, consulting agreements, and confidentiality agreements with vendors and sites.
- Ensure Trial Master File is current and maintained.
- Ability to remain flexible and step out of comfort zone.
- Desire to pitch in at any level.
- Manage external vendors, including CROs.
- Travel up to 25%.
Desired Professional Experience
- Proven track record of independent study management and ability to manage a single study independently.
- A minimum of 2 years monitoring experience is required.
- Robust project management and prioritization skills.
- Experience with clinical databases and document repositories.
- Experience with word processing, data tracking, and vendor portals.
- History of success working independently with minimal supervision or guidance.
- Strong attention to detail and highly organized.
- Possess solid time management and prioritization skills.
- Experience in phase I-III trials, including global experience.
- Solid grasp of regulatory processes.
- Excellent communication skills, both oral and written.
- Strong organizational abilities.
- Proficiency in MS Word, Excel, PowerPoint, and Outlook.
- Flexible and able to adapt to changing priorities quickly.
- Ability to identify risks, evaluate impact, and communicate impact and mitigation to the team.
- Minimum of 5 years of experience in clinical research, with at least 2 years of experience as a CRA performing on-site monitoring.
- BA/BS degree, preferably in the life sciences or related field.
- An attractive compensation package commensurate with experience will be provided.
Blade Therapeutics Is An Equal Opportunity Employer