Project Manager

About Us:   

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.  

 

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. 

 

Job Summary:  

Responsible for overseeing clinical trials and ensuring that they are conducted in compliance with regulations and guidelines. Responsible for ensuring that team complete all projects on time and within budget.   

  

Essential Responsibilities and Duties: 

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. 
You will be supporting the management of multidisciplinary teams and their delivery again clear objectives, quality standards, timeline commitments and budgets. 
You will be responsible for managing the research and development process and ensuring that the data and documents are managed in compliance with regulatory standards. 
You will be supporting the design and executing of preclinical and clinical studies under close study of GPL whilst supporting the development and implementation of project plans through research and development stages. 
Responsible for setting up and maintaining information repositories including projects folders and making sure everything is compiled to quality. 
Recognize issues and potential risks within the projects proactively manage them to resolution and/or mitigation with the assistance of project leads. 
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.  

 

Education/Experience/Skills: 

Must be able to effectively communicate verbally and in writing. 
Bachelor’s degree in related field such as life sciences, nursing, or healthcare preferred. 
Experience in clinical research, including experience managing clinical trials. 
Knowledge of regulatory requirements and guidelines. 
Excellent communication skills. 
Comfortable managing multiple tasks. 
Problem-solving aptitude. 

 

Working Conditions  

Indoor, Clinic and Office environment. 
Essential physical requirements include sitting, typing, standing, and walking. 
Lightly active position, occasional lifting of up to 20 pounds. 
Reporting to work, as scheduled, is essential. 

 

CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.