CLINICAL PROJECT MANAGER
Job Title: Clinical Project Manager
Classification: Full-time, Exempt, Salaried
Longeveron LLC is an established biopharmaceutical company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials involving novel stem cell products. We are seeking a dynamic and experienced professional to grow with our team as a Clinical Project Manager. Now is an exciting time to join Longeveron. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. Our work atmosphere is fast paced, stimulating, team based and results oriented.
The Clinical Project Manager (CPM) helps lead the clinical research programs both in the US and internationally. This position drives planning and decision-making, develops implementation strategies and leads efforts for projects. This position will work with team members to create and maintain project plans and timelines, which may include budget, definition, scope, project staffing, financial resources allocation, dependencies and target dates. The CPM should be highly organized and possess the proven ability to juggle multiple competing tasks and demands. This position requires a self-starter with a positive and flexible attitude, who can work independently and also collaborate closely and positively with team members.
Essential Duties and Responsibilities
• Plays instrumental role in clinical trial organization and oversight, participates in determining the feasibility of research sites, site selection and finalization of site and vendor Clinical Trial Agreements and budgets, oversees trial initiation at research sites, sets up Trial Master File, liaises with research sites and Clinical Research Organizations, and maintains Good Clinical Practice (GCP) standards;
• Prepares and reviews documentation related to clinical trials;
• Interacts with consultants, vendors and certain governmental agencies to maintain timely and compliant trial initiation and conduct;
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Communicates effectively across all functional groups so that schedules and scopes of the projects are clear;
• Assists in the development of project budgets and tracks project-related costs;
• Develops project timelines and tracks contract deliverables (in Gantt charts or similar tool);
• Assembles, analyzes and reports project metrics for internal and external stakeholders;
• Identifies project issues such as resource, technical or scheduling constraints, and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions;
• Ensures that projects are completed on time, within budget and scope, and conform to pre-established quality standards;
• Assists with the development of project plans and monitors for accomplishment;
• Collaborates with internal and external stakeholders while maintaining sensitive, confidential and trade secret information;
• Works hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary) and position requires frequent domestic and international travel as needed; and
• Other duties as assigned.
Requirements and Qualifications
• Four or more years of clinical operations experience, including as a CPM and/or Clinical Trial Manager (CTM) with increasing levels of responsibility in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
• Bachelor’s Degree in Life Sciences, Nursing Licensure or Pharmacy, at minimum.
• Demonstrated working knowledge of GCP, FDA and ICH regulations and guidelines required. Previous experience in the conduct of global clinical trials preferred.
• Regulatory experience is required.
• Understanding of biotech or drug product development activities and of multi-project planning and coordination is required.
• Demonstrated leadership, interpersonal, problem solving, and conflict resolution skills.
• Thrives in a start-up environment where it is critical to take initiative, and get things done with limited instruction and oversight.
• Advanced proficiency in Outlook, Word, Excel, PowerPoint, etc.
• Read, write and speak fluent English; excellent verbal and written communication skills
Work Environment: This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 20% of work time.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Longeveron LLC is dedicated to a diverse workforce and Drug Free work environment.
Qualified candidates are encouraged to apply.
Compensation: Commensurate with experience. Eligible to participate in equity incentive plan, retirement plan, healthcare benefits, paid time off and discretionary bonus.
For more information, visit www.longeveron.com
Submit applications to: Careers@longeveron.com
Longeveron LLC is an Equal Opportunity Employer