SENIOR CLINICAL STUDY MANAGER
POSITION SUMMARY:
We are seeking an experienced and driven Senior Clinical Study Manager to lead the cross-functional Clinical Study Team and ensure successful delivery of assigned clinical studies. In this role, you will be
responsible for the daily management of a diverse program of clinical trials, including management of contract CROs conducting company-sponsored clinical trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Work with CROs to ensure that patient enrollment and data collection are completed in accordance with study timelines and objectives; escalates risk to timelines and budget as needed.
- Work with CRO to revise scope of service agreements, budgets, plans, and detailed timelines, and ensure that performance expectations are met.
- Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs; attend co-monitoring visits as required.
- Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
- Review and contribute to study Protocols, eCRF design and completion guidelines, pharmacy manuals, Informed Consent Forms, and other study-related documents.
- Coordinate/plan investigator meetings and/or site and CRA training.
- Perform financial management, including review and approval of site and vendor invoices.
- Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
- Perform review and QC central clinical files and trial master files.
- Identify potential study issues and recommend and implement solutions or corrective actions as needed.
- Work with CRO and/or core team members to address issues and risks associated with achieving the study deliverables and develop risk mitigation plan.
- Serve as a liaison and resource for investigational sites, review investigator contracts and site payments.
- Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
- Organize and manage internal team meetings and other trial-specific meetings.
- Participating in the development, review and implementation of departmental SOPs and processes.
- Other projects as deemed appropriate.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
Required:
- Bachelor's or master's degree in a scientific or health care field is required with 6 to 10 years of clinical trial management experience or an appropriate combination of education and experience.
- Experience in CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
- Clinical operations experience at a small or mid-size company.
- Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
- Experience working independently and in a team environment, being flexible and adapting in a changing environment.
- Ability to travel up to 25%.
- Ability to multi-task/ prioritize and time management of daily activities.
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint).
- High attention to detail.
- Demonstrates a high level of accuracy and effective oral and written communication skills.
- Flexibility within a rapidly changing environment.
- Excellent ability to work in a goal and team-oriented setting.
- Well-developed organizational skills
