Harvest Integrated Research Organization (HiRO) is a global, boutique Clinical Research Organization (CRO) that streamlines and accelerates cross-border clinical trial pathways for pharmaceutical and…
Harvest Integrated Research Organization (HiRO) is a global, boutique Clinical Research Organization (CRO) that streamlines and accelerates cross-border clinical trial pathways for pharmaceutical and…
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.
We are growing our US team and are searching for an experienced Senior Clinical Project Manager to join our team.
As a Senior Clinical Project Manager you will conduct and manage all phases of clinical research studies from initiation to close-out by leading both internal and external teams, provide overall leadership to all functions to achieve operational excellence and quality deliverables, on time, within budget and in accordance with SOPs, policies, and practices. This position is responsible for project execution with profitability, quality and client satisfaction.
Key Responsibilities
Preferred experiences and skills
Come join a growing team!
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.
***This role is NOT open to agency solicitation.***
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Responsible for Master Service Agreement (MSA), Work Order (WO) and budget review to ensure all pre-award activities are all completed.
Participate in proposal development.
May lead bid defense presentations in partnership with Business Development and cross-functional staffs.
Lead the kick off meeting to establish client expectations for project delivery, ensure project scope, budget and resource requirement are well delivered to project team.
Lead the project team for project financial management, ensure overall project profitability from resource assignment review, change order management and budget and timeline control.
Responsible for developing a project plans and tools guideline by following applicable SOPs in accordance with project requirement to ensure highest quality delivery for project execution.
Responsible for Project Quality by identifying and managing quality issue proactively through team communication, report/metrics review. Collaborate with project team for Corrective Action and Preventive Action (CAPA) implementation for audit findings or any project related issue.
Responsible for Project Level Deviation and Protocol Deviation (PD) management, ensue project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
Responsible for system compliance, ensure overall system quality with regular update and review from project team.
Work with team to prepare and update project plans, project status and other administrative reports and submit to clients as required by the contract exhibit, and other internal stakeholders
Responsible for risk management, leading problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate risk.
Prepare and lead project internal meeting, ensure project objectives are met; ensure the on-going communication to team of the scope of work, timeline and project goals and input from client for any significant changes.
Prepare and lead external meetings, ensure client are fully informed of project progress, pro-active decisions/solutions and how the project objectives are being achieved.
Responsible for Vendor Management from vendor qualification and selection, ensure vendor to meet study requirement and support project deliver with highest quality.
Provide input to line managers of their project team members performance relative to project tasks. Recommend team members further professional development, support staff development, and mentor less experienced Project Managers.
Oversee all administrative closeout procedures are completed including project archiving and TMF return.
5 years clinical research experience including 2 years project management experience or equivalent combination of education, training, and experience.
Previous and recent experience working in project management within a Contract Research Organization (CRO).
Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience. Typically viewed as having a specialty within discipline. Preferred Therapeutic Areas: Oncology, Cardiovascular & Metabolic, Endocrinology, CNS.
Strong communication and interpersonal skills.
Strong organizational, problem-solving, presentation and time management skills.
Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
Strong team leadership, conflict management and customer service skills.
Equipped with Financial Management skills
Learn to establish and maintain effective relationships with workers, managers, and clients.
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
Travel may be required.
Bachelor’s degree in a life-sciences related field or equivalent combination of education, training and experience.
