Precision for Medicine is hiring a Clinical Trial Manager to lead the planning, conduct, and oversight of clinical studies. The successful candidate will have 5-8 years of clinical research experience and a bachelor's degree in a science or health-related field.
Requirements
- Primary clinical point of contact with the client
- Collaborate with PM on monthly invoicing and variance management of clinical budget
- Develop study related clinical documents
- Identify and develop training needs for CRAs and third-party vendors
- Generate potential site list from key stakeholders and drive site feasibility process
- Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
- Develop and finalize the country recruitment/retention strategy
- Develop timely and effective communication and good working relationships with investigators and study team
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
- Support in planning and conducting investigator meetings
- Review and/or approve of IP release packages
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilize metric reporting to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
- Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
- Work closely with PM for project-specific resourcing issues
- Escalate pertinent CRA performance and site compliance issues when necessary
- Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
- Manage processes for investigational product (IP) including drug accountability and reconciliation
- May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
- May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
- May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
- May manages workload of supervised staff with continued assessment and adjustment as needed
- Perform other duties as assigned by management
Benefits
- Flexible working hours
- Comprehensive training program
- Professional development opportunities
- Employee recognition program
- Cultural diversity and inclusion
- Professional networking opportunities
