Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies.
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
- Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
- Generate and utilizes metric reporting to ensure that the study is conducted per plan
- Responsible for eTMF implementation and management
- Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA)
- 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)
- When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
- Support business development and marketing activities as appropriate
- May negotiate site budget and investigator contract
- 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
- May perform clinical data review of patient profiles, data listings and summary tables, including query generation
- May have line management responsibilities
Benefits
- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation
