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Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. As an emerging global CRO, HiRO collaborates closely with biotech and pharmaceutical companies, aiming to efficiently bridge the gap between laboratory research and market commercialization. Our Team Members are curious and determined, always looking to transform challenges into opportunities. Our mission is to provide cutting-edge and capital-efficient solutions, ultimately benefiting patients worldwide.
Job Summary: The Senior Clinical Trial Manager (CTM) provides leadership, mentoring, and technical support to the clinical monitoring team to ensure quality of deliverables and achievement of financial goals. May provide oversight and coordination of CRA(s)/CTM(s) working across regions and/or countries to ensure clinical project and site deliverables are met.
Key Responsibilities:
Allocate workload and site assignments within the clinical monitoring team.
Ensure quality of the clinical monitoring deliverables within a project and maintain proper visibility of its progress by the use of tracking tools. May include the development of the Clinical Management Plan (CMP).
Ensure efficient dissemination of information across the CRA team.
Interact with the client and other functional departments related to clinical monitoring activities and deliverables.
Ensure alignment of clinical activities to budget.
Identify quality issues within the study through regular review of site communications, monitoring visit reports, etc. to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties.
Support development of study materials and present at investigator or study launch meetings.
Support the identification of out-of-scope activities including the completion of clinical monitoring aspects of change orders.
Participate in business development proposals, defense meetings and proposal development.
Coaches and mentors junior CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Also sets priorities for the CTM team to complete and manage on a regional and site level.
May evaluate staff’s competency to perform visits/site contact independently via Performance Assessment Visits according to company standards and process.
Understands the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. Is accountable for the clinical teams understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP, and risk plans.
Collaborates with other functions to ensure site compliance and delivery according to protocol, ICH/GCP and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for Clinical Scope.
Qualifications:
Preferred 5 years prior clinical research or monitoring experience, minimum 2 years in a Clinical Trial Manager/Clinical Trial Lead role.
Demonstrated ability to lead and align team in the achievement of project milestones.
Demonstrated capability of working in an international environment across regions, countries, and time zones.
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements.
Oncology experience.
Prior direct radiopharmaceutical clinical trial experience required
Must demonstrate good computer skills and be able to embrace new technologies.
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince and persuade.
Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigating potential threats to successful conduct of a clinical research project.
Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
Proficient in the use of relevant Office applications.
Ability to travel as necessary.
Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
What We Offer:
A dynamic and innovative workplace that embraces new ideas.
Compensation package & shall be commensurate with experience.
Supportive colleagues that are driven by their passion for our mission.
Opportunities for accelerated career advancement as the team grows.
We offer a comprehensive benefits package including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
We are committed to providing equal employment opportunities for all. HiRO does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.
Contact us:
If you are interested in this role, please apply. We also encourage you to follow our company page on LinkedIn for the most up to date company news and job postings.
At HiRO, we believe that curiosity drives innovation, hard work fuels success, and creativity inspire solutions. We’re looking for individuals who thrive on exploring new ideas and approaches. If you are passionate about your work and eager to contribute to a collaborative and inclusive environment, we want to hear from you.
Applicant Privacy & GDPR Notice
HiRO (Harvest Integrated Research Organization Corp.) is committed to protecting the privacy and security of the personal information you share with us during the recruitment process.
When you apply for a position with HiRO, we collect and process personal information necessary to evaluate your application, communicate with you regarding employment opportunities, manage our recruitment and hiring processes, and meet applicable legal and regulatory requirements.
As a global organization, your personal information may be processed by HiRO and its affiliated companies and authorized service providers in countries outside of your country of residence. Where required, HiRO uses appropriate safeguards for international transfers of personal data.
Depending on where you are located, you may have rights regarding your personal information, including the right to access, correct, delete, restrict or object to certain processing, request portability, or withdraw consent where consent is the basis for processing.
HiRO does not sell applicant personal information or use applicant information for targeted advertising.
For additional information regarding how HiRO collects, uses, retains, shares and protects applicant information, please review our Applicant Privacy Policy .
Questions or requests regarding your personal information may be directed to .
