Job Description

Primary Function

DiaMedica is a clinical stage biopharmaceutical company bringing their lead candidate, DM199, through clinical development.

DM199 (rinvecalinase alfa) is a synthetic form of human tissue kallikrein-1 (rhKLK1) in clinical development for acute ischemic stroke and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis.

The Senior Clinical Trial Manager will be responsible for the operational management and the oversight of clinical trials within a clinical development program. This individual will be responsible for the successful execution of clinical trials from the protocol concept through the clinical study report, ensuring completion of study deliverables. Providing oversight of the CRO and other third-party vendors on assigned study. The Senior Clinical Trial Manager will work closely with a Project Leader, or Pharmacovigilance, Regulatory, etc., and will report into the Clinical Operations Director.

Major Responsibilities

• Assisting in identification and hiring of appropriate CROs and third-party study vendors
• Assisting with CRA and third-party vendor training on protocols and practices
• Developing and maintaining good working relationships with investigators and study staff
• Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Identifying, selecting, and monitoring performance of investigational sites for clinical studies
• Investigating queries, monitoring discrepancies
• Managing investigational product (IP) accountability and reconciliation process
• Negotiating and managing the budget and the payments
• Overseeing performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to Clinical Operations Manager
• Performing clinical data review of data listings and summary tables, including query generation
• Performing initial review of CRO and other third-party study vendor invoices
• Planning and conducting investigator meetings
• Reviewing key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determining appropriate action in conjunction with study team
• Reviewing or approving of IP release packages
• TMF maintenance
• Tracking and reporting on progress of study including site activation, patient enrollment, monitoring visits
• Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents
• Partner with Quality Assurance as needed

Qualification Requirements

• At least 2 years of trial management experience
• At least 6 years of clinical trial experience in Pharmaceutical, Biotech, or a CRO company is required
• Bachelor’s degree or equivalent combination of education/experience in science or health-related field required

Work Environment & Pay Transparency

This is a remote position.

The base salary range for this position is $129,000 – 177,000; the exact salary depends on several factors such as experience, skills, education, and budget. In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results. It is eligible to participate in our long-term incentive program.

DiaMedica offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and vacation time, and many others. Many of these benefits are subsidized or fully paid for by the company.

EEOC Statement

DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.