Clinical Project Manager at Vivex Biologics

Description

The Clinical Project Manager (CPM) will contribute to the design, planning of assigned clinical studies and will oversee the execution, and monitoring of assigned clinical studies to support regulatory approvals, product development, and post-market evidence generation. The CPM ensures that clinical studies are conducted in accordance with applicable regulatory standards (FDA, ISO 14155, ICH-GCP), corporate SOPs, and timelines. The CPM will be responsible for overseeing the successful and timely execution of assigned clinical studies for the organization. This role requires cross-functional leadership, vendor oversight, and a strategic mindset to drive clinical excellence within a high-performance organization.

Requirements

Duties and responsibilities

• Contributes to the development of clinical strategies aligned with regulatory and commercial goals.
• Collaborates with R&D, Regulatory, and Marketing on clinical trial designs and endpoints.
• Prepares and presents findings of assigned studies to internal and external stakeholders.
• Leads and manages the execution of assigned clinical studies.
• Oversees protocol development, site selection, budgeting, contracting, and CRO/vendor management for assigned studies.
• Ensures adherence to timelines, budgets, and enrollment targets.
• Manages resources and quality of clinical projects.
• For assigned activities, understands project scope; manages site and study level activities.
• Ensures all clinical activities for assigned studies are compliant with FDA, ISO, and ICH-GCP regulations.
• Prepares and reviews study documents including protocols, informed consent forms, monitoring plans, and clinical study reports.
• Manages the finalization of clinical project documents according to the Protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.
• Collaborates with investigators and other clinical staff to ensure the quality of research.
• Serves as a liaison between clinical, regulatory, marketing, customer care, quality, and commercial teams.
• Interfaces with Key Opinion Leaders (KOLs), Principal Investigators, and site personnel to ensure high-quality data collection and strong site relationships.
• Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines.
• With the oversight of Clinical Affairs leadership, plans and oversees assigned clinical studies, from patient recruitment to data collection and lock.
• Supervises the collection, storage and processing of data to maintain integrity and accuracy.
• Oversees data integrity, query resolution, and interim analyses in partnership with Data management, Clinical Affairs colleagues, and Biostatistics vendors.
• Identifies study risks and proactively implements mitigation strategies.
• Ensures all sites and project-specific team members are trained and compliant with applicable requirements.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Supports development of documented departmental procedures, such as SOPs, Work Instructions, and associated forms and templates.
• Other duties, as assigned.
  
  

Skills

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Detail-oriented with strong project management capabilities
• Strong problem-solving and decision-making abilities
• Excellent communication, teamwork, organizational, interpersonal, and critical thinking skills
• Ability to plan, multi-task and work in a dynamic team environment
• Strategic thinking with strong executional focus
• Collaborative leadership and ability to influence cross-functional teams
• Must be able to adapt quickly, with the oversight of Clinical Affairs leadership, to changing priorities to achieve goals / targets.
• Proficiency in MS Office applications
• Experience in more than one therapeutic area is advantageous
• Full working proficiency in English
  
  

Qualifications

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related field
• 5–8 years of experience in clinical research, with at least 3 years in a management or lead role
• Prior experience as a Clinical Project Lead or Clinical Manager
• Strong knowledge of FDA regulations, ISO 14155, and ICH-GCP
• Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
• Experience working with CROs and clinical trial vendors
  
  

Working conditions

Office Environment, Laboratory Environment.

Able to travel up to 20%, domestically and internationally

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.

VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation and training.

VIVEX Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.