The Clinical Project Manager (CPM) candidate will possess the skills needed to management all aspects of the clinical trial team activities for assigned clinical projects. 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. The CPM will work closely with the Executive Vice President of Operations as well as additional clinical and regulatory team members to meet goals and deadlines. A wide degree of creativity and latitude is expected. Must have excellent oral and written communication skills.
The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- 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.
- Maintains the strictest confidentiality of all activities.
- Team player, engendering credibility and confidence within and outside the company.
- Faithfully performs any other tasks requested by the Chairman, President & CEO.
- Act in accordance with Landos’ policies and in alignment with the corporate culture.