Basic Information

Job Category: Operations/Production

Location: Rockville, Maryland, United States

Date published: 05-Apr-2022

Job type: Full Time

Description and Requirements

About the role

We are currently seeking an experienced Clinical Trial Manager (CTM) in Rockville, MD.
Contractor to Full-Time
Willing to travel up to 20%-30% if required

The clinical trial manager is a member of a matrix team dedicated to the implementation of clinical research studies and development of programs and clinical trials. CTM is responsible for assisting clinical project manager managing all assigned clinical projects, site management, and CRA management.

Duties and Responsibilities:
Supporting regulatory affairs, data management, medical writing, biostatistics, medical affairs to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines
Assisting CPM track project performance, site level progress to ensure all projects are delivered on-time, within scope and budget
Responsible/Assisting for preparation of clinical operation documents and study plans (PMP, CMP, etc)
Develop clinical Standard Operating Procedures (SOPs) and Project Specific Operating Procedures
Responsible and capable of preparing/revising/finalizing study essential documents, regulatory binders independently.
Lead site contract and budget negotiations and implementation
Oversee clinical sites overall performance to ensure meeting recruitment goals and deliver high quality data on time.
Assisting CPM manage all assigned clinical trials from startup phase through close out activities
Provide clinical related training for R&D team members and/or other department members
Review monitoring trip reports completed by CRAs
Assisting CPM with site identification, feasibility, and selection process
Provide direct supervision of CRAs and attend on-site monitoring with CRAs as needed
Assisting CPM plan and participate in Investigator Meeting/Client meeting/Bid defense meeting
Maintaining the highest standard in complying with the company regulations and behavior standards. 

Bachelor’s degree in life sciences, or other relevant discipline required, advanced degree preferred.
Minimum of 6 years’ clinical research experience as clinical trial manager in the CRO company is required.
Direct site management experience is required
Willing to travel up to 20%-30% if required

Preferred Therapeutic Areas Experience:
Cardiac Disease

Skills and Abilities
On-site clinical monitoring experience as CRA in the past is preferred
Solid understanding of FDA and other regulatory requirements
Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
Strong interpersonal and communication skills
Proficiency with MS Office suite (word, excel, PowerPoint, and outlook)
Working knowledge of MS Project for development and update of clinical study timelines

Willing to travel up to 20%-30% if required.

Tasly Pharmaceuticals, Inc. is an Equal Opportunity Employer