Landos Biopharma is an emerging clinical-stage biotech company looking for a highly motivated individual with an A+ attitude to help manage agile/lean operations. The ideal candidate will have strong work ethics and interested in building a career in biotech/biopharma. A successful candidate will be a motivated, self-starter with proven ability to follow through. A wide degree of creativity and latitude is expected. Must have excellent oral and written communication skills.
The candidate will be aligned with three fundamental pillars of Landos’ corporate culture: 1) Be bold and decisive, 2) Never give up, and 3) Do the impossible. For more information please visit: http://careers.landosbiopharma.com/
- Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate.
- Plan PSV and SIVs.
- Reviews and develops CRFs.
- Resolve patient eligibility and protocol deviation issues.
- Assist in preparing Clinical Study Reports and annual safety reports.
- Review monitoring reports for accuracy, completeness and conformance with SOPs.
- Maintains frequent contact with and work effectively with investigators and coordinators.
- Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.
- May monitor/audit clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by CRO personnel.
- Track items related to CDAs, budget and contract completion status.
- Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
- Perform clinical data review of data listings and summary tables, including query generation.
- Review and/or submission of research ethics committee/regulatory documentation.
- Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
- Develop and maintain good working relationships with investigators and study staff.
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Assist with establishing and tracking clinical timelines and appropriate performance metrics.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience).
- Investigate queries, monitor discrepancies as applicable.
- Manage/oversee investigational product (IP) accountability and reconciliation process.
- Responsible for review or approval of IP release packages.
- Collect/review/track site regulatory documents
- Serve as primary/secondary contact for clinical sites and vendor personnel as delegated
- Prepare/maintain study-specific Trial Master Files (TMF). Periodically review TMF content to ensure completeness
- Manage clinical supply (re)order process and inventory. Respond to (acknowledge receipt/fill) order requests in a timely manner.
- Participate in project specific meetings and coordinate department meetings
- Maintain department calendars and perform other administrative duties as needed
- Other tasks as needed by the company’s management
- Minimum of 3 years’ experience as a Clinical Project Manager
- Bachelor’s degree or equivalent, in a biomedical, life science or related field of study. Competency in ICH-GCP and a strong interest in clinical research.
- Previous experience with Phase 1, 2 and 3 studies essential
- Monitoring experience and Co-monitoring experience
- Understand technical, scientific and medical information
- Understand clinical study budgets.
Skills & Proficiencies:
- Biotech and biopharma experience
- Reliable, trustworthy and loyal
- Ability to thrive in a fast-paced, deadline-driven work environment
- Data Entry Skills
- Data Processing Skills
- Reporting Skills
- Critical Thinking and Problem-Solving Skills
- Planning and Organizing
- Communication Skills
- Team Work
- Follow through
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off
- Flexible schedule
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