General Scope and Summary
Q32 Bio is searching for an independent, collaborative Clinical Study Manager (CSM) to lead the operations of one of our clinical stage programs. The CSM will lead the implementation of one or more of our studies and will manage the relationships with our internal study teams as well as close management of external CROs.
This position will report to the Vice President of Clinical Development Operations.
Roles and Responsibilities
- Serves as study lead and primary (internal and external) contact
- Leads and manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, US and Ex US regulatory guidelines and operate withing established timelines
- Manages outsourced clinical study functions, which may include contracted investigational supply, data management, biostatistics, and central laboratory
- Generates and presents frequent study status updates and reports to sponsor
- Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
- Oversees and tracks patient recruitment and pro-actively identifies ways to prevent recruitment delays
- Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones
- Ensures accuracy of reports and material work product
- Presents at project meetings such as investigator meetings and new client meetings
- Updates management accurately and regularly through frequent communication
- Pro-actively Identifies issues and develops problem-solving strategies to ensure study timelines are met
- Manages subject accrual, retention, and compliance
- Ensuring that study Trial Master File is maintained and up to date and manages TMF audits as needed
- Writes and updates SOPs
- Prepares for and participates in third-party audits and regulatory inspections
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned.
- Minimum BS/BA from an undergraduate program or equivalent experience
- 5 years’ clinical operations/ management experience
- Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Excellent communication and interpersonal skills with customer service orientation
- Proficient with MS Office Suite, particularly Word and Excel
- Self-starter who thrives in a collaborative team environment
- Flexibility to travel up to 20% of time
Interested parties should send their CV to email@example.com.