Senior Clinical Research Associate Manager

Senior Clinical Research Associate Manager

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DiaMedica Therapeutics

Minnetonka, MN, USA Hybrid

Full time

$130-175k (Annually)

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DiaMedica Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments where there is a significant unmet clinical need or where no current therapies are available. We are committed to improving the lives of people suffering from preeclampsia and acute ischemic stroke and we are currently advancing our lead candidate, DM199, through the clinical development process.

As a Senior Clinical Research Associate (CRA) Manager, you will be responsible for overseeing the operational management and execution of clinical trials within a clinical development program and leading and mentoring a team of Clinical Research Associates. You will ensure the successful completion of clinical trials from the protocol concept to the clinical study report, fulfilling all study deliverables and ensuring compliance with regulatory requirements and clinical best practices. In this role you will also collaborate closely with Project Leaders, Pharmacovigilance, Regulatory, and other key stakeholders. Additionally, CRA Managers provide oversight of the Clinical Research Organization (CRO) and other third-party vendors assigned to studies.

Major Responsibilities

Team Management and Leadership:

Guide, train, develop, and mentor internal Clinical Research Associates,

Oversee the performance of Clinical Research Organizations (CRO) and third party vendors

Allocation of resources and assigning resources to projects based on experience, workload, and projects needs.

Participate in the recruitment, training, and onboarding of new CRAs.

Clinical Trial Oversight

Assist in identifying and hiring appropriate CROs and third-party study vendors

Ensure that studies are carried out according to the regulations, clinical best practices, and study-specific manuals and processes.

Oversee site selection, trial planning, initiation, monitoring, and execution

Monitor study progress and conduct co-monitoring visits and quality control checks

Resolve site issues and serving as an escalation point for CRAs

Negotiate and manage study budgets and payments, including initial reviews of CRO and other third-party vendor invoices

Manage investigation product (IP) inventory, reconciliation, and storage, verifying proper dispensing and administration.

Compliance and Quality Assurance

Ensure site documentation is adequate and compliant

Report and manage protocol deviations and adverse events

Support audit and inspection readiness activities

Communication and Collaboration

Maintain effective communication with study teams, CROs and third-party vendors, project managers, regulatory teams, investigators, and other key stakeholders

Provide feedback for continuous improvement and adapts to changing project priorities

Collaborate with internal teams and external vendors to ensure smooth study conduct

Qualification Requirements

Qualification Requirements:

Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or or equivalent combination of education/experience in science or health-related field

7+ years progressive CRA experience

2+ years of CRA management experience within clinical research organizations, pharmaceutical, or biotech

In-depth knowledge of clinical trial processes, GCP, and regulatory requirements (FDA, EMA, ICH, etc.).

Excellent organizational, communication, and interpersonal skills.

Ability to manage multiple projects and priorities in a fast-paced environment.

Willingness to travel as required.

Preferred Requirements:

Advanced degree

Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).

Certification (e.g., ACRP, SOCRA) is a plus.

Strong problem-solving and conflict resolution skills

Work Environment & Pay Transparency

This position is a remote or (hybrid) environment with some travel required.

This position resides within a normal office working environment with very little travel required.

The base salary range for this position is $130,000 - $175,000; 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.

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DiaMedica Therapeutics

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