What are the responsibilities and job description for the Clinical Project Manager position at Hematogenix Laboratory Sv?
Want a job with greater meaning and higher purpose? Every day Hematogenix employees are warriors fighting a noble and global war on cancer. Helping patients every day, and helping partners every day – with our diagnostic and research services.
Hematogenix is looking for talented and highly motivated individuals to join our team. We offer a competitive benefit package and career development opportunities to help you achieve your highest professional and personal goals. We are eager to show you all we have to offer and how you can grow with us.
Hematogenix is a specialized contract research organization and clinical laboratory with a global presence. Our team of board-certified clinical, anatomic and research pathologists work in conjunction with top scientists from around the world to provide quality testing, consultation, and guidance for all aspects of the company’s pharma and diagnostic services.
Job Purpose:
The Project Manager is responsible for successful planning of global phase II/III registrational clinical trials, study start up activities, logistics set up and support, study sample and data query management, monitoring turnaround times, data reconciliation and close out activities. Includes but not limited to:
- manage the scope of clinical trial projects, ensuring objectives, timelines, quality standards, and budgets constraints are fully met.
- anticipate and respond to any challenges that may occur during the lifecycle of a project.
- deliver excellent customer service to clients and other project stakeholders.
- reports to Hematogenix Executive Team
Accountabilities/Work Activities:
Study Initiation
- Participate in meetings with potential clients to fully understand a project’s objectives and timelines.
Planning & Design
- Identify required activities of projects.
- Contribute to the creation of a mutually agreed upon Scope of Work documents with Sponsors.
- Liaison with Hematogenix SMEs to support complex biomarker projects
- Create study specific Laboratory Manuals and maintain required regulatory documents.
Executing
- Host in-house or remote initiation meetings with all project personnel to ensure participants understand their individual contributions, as well as overall study objectives and timelines.
- Develop and train project team as clinical trial projects formally begin
- Create and maintain study tracking documents to ensure timelines are adhered to as applicable to each specific study or Sponsor requirements.
Monitoring & Controlling
- Continually monitor progress of projects
- Ensure project supplies and resources are being adequately maintained.
Study Closing
- Support all Close out activities depending on the scope of services as applicable to the study design or Sponsor’s requirements.
- Participate in any Close Out Visits
- Support study audits as needed.
Experience and Education
- Minimum Bachelor of Science degree with experience in Clinical Laboratory Science
- 2-3 years’ experience in Project Management supporting Phase II/III global clinical trials.
Skills and Qualifications
- Knowledge of GCP/CAP/CLIA and clinical project management processes
- Knowledge of global clinical research industry and associated regulations
- Must be able to communicate effectively and persuasively, both verbally and in writing, with clients, all levels of in-house Hematogenix personnel, and other project stakeholders
- Personal computer skills (Microsoft Word, Excel, Power Point, etc.)
- Ability to ambulate throughout the office and laboratory.
Benefits we Offer:
- Medical
- Dental
- Vison
- Life
- 401k
- PTO
- Competitive Salary
Contact Information:
jobs@hematogenix.com; www.hematogenix.com
Hematogenix provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
