What are the responsibilities and job description for the Hybrid Clinical Project Manager position at Actalent?
MUST HAVES:
- MUST HAVE Medical Device Clinical Trial Management Experience
- MUST HAVE experience working with Study Start Up
- MUST HAVE the ability to go on site 1-2 days a week
Job Summary
Working to support the development of innovative and transformative technologies, the Clinical Project Manager will develop and execute clinical studies aimed at demonstrating the safety and efficacy
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Experienced Project/Program Leader with proven track record of independently, passionately and effectively driving the planning and execution of operationally achievable study plans
Efficiently manages simultaneous clinical projects from concept through clinical study report completion
Responsible for crafting clinical protocols, informed consent forms, investigational plans, study materials (eg, training materials, case report forms, study files, supplies requirements)
Participate in cross-functional teams to understand clinical program objectives with the broader business goals
Establish project objectives and work plans including budgets and resource requirements
Delegate assignments to functional area team members and track key project activities to successful completion
Demonstrate ability to proactively identify and resolve product and project risks
Ensure clinical research is conducted in accordance with FDA Regulations, GCPs, ICH guidelines, International regulations and internal SOPs
Evaluate and approve/qualify clinical sites for studies to ensure compliance with applicable regulatory regulations
Develop and track study budgets, including invoice review and accounting
Manage and oversee site initiation and training to clinical study personnel at sites
Manage on-going monitoring activities: scheduling, report review and approval
Negotiate and prepare study contracts with clinical sites
Support regulatory filings and submissions as it pertains to clinical study data
Participates in the development and revision of Work Instructions, Guidance Documents, and Standard Operating Procedures (SOPs) as they relate to regular document maintenance or as a result of continuous improvement efforts
Ability to come to local Office, 1-2 days/week or as needed
Qualifications
Education & Experience
• BS Degree in health-related field; MS preferred
• PMP Certification and international experience desirable
• 2-5 years of experience in clinical research and project management with demonstratable track record;
Skills
• Driven self-starter with excellent self-management skills
• Strong working knowledge of Good Clinical Practices (GCP) and FDA regulations related to clinical research.
• Strong Attention to detail
• Leadership skills, influence management and collaboration skills
• Experience leading cross-functional teams and projects
• Experience with imaging and/or medical products preferred
• Knowledge of FDA Regulations, GCPs, ICH guidelines, International regulations
• Experience in management of project risks
• Strong written and verbal communication skills
• Must possess excellent relationship building skills with team members, peers, and senior leaders accessing their needs and ask the right questions to surface essential requirements information
• High degree of competency in Microsoft suite
• Experience with biostatistics or data analytics a plus
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $65 - $90
