Clinical Trial Manager
Company: Tasly Pharmaceuticals Inc.
Posted on: June 15, 2022
Tasly Pharmaceuticals Inc. 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
- Assisting CPM track project performance, site level progress to
ensure all projects are delivered on-time, within scope and
- 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
- 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
- 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.Requirements:
- 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 requiredPreferred
Therapeutic Areas Experience:
- Cardiac Disease
- OncologySkills and Abilities
- On-site clinical monitoring experience as CRA in the past is
- Solid understanding of FDA and other regulatory
- 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
- Working knowledge of MS Project for development and update of
clinical study timelinesWilling to travel up to 20%-30% if
Tasly Pharmaceuticals, Inc. is an Equal Opportunity Employer
Keywords: Tasly Pharmaceuticals Inc., Rockville , Clinical Trial Manager, Executive , Rockville, Maryland
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