Clinical Trial Manager

Acrotech Biopharma Inc • East Windsor Township, NJ

1d • Onsite

About The Position

The Clinical Trial Manager will lead key aspects of assigned clinical trial(s) and demonstrates a good level of knowledge of clinical methodologies, organizational, project management and leadership capabilities. The role works under the guidance and direction of the Clinical Program Lead. Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters. Works to ensure adherence to a standardized approach to clinical trial management. Reviews, tracks and files study specific documents as well as creates and updates study specific reports. Exercises discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks.

Requirements

• CRA experience and a minimum 3-5 years of direct clinical trial management experience
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• A team player and ability to take initiative and lead
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
• Proficient written and verbal communication skills
• Bachelor’s degree in a scientific or healthcare discipline is required

Nice To Haves

• Master's degree preferred

Responsibilities

• Acts as a regional lead for large global studies
• Contributes to the content and review of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc. Coordinates and tracks the distribution and retrieval of documents.
• Assists in the set up and perform oversight of the electronic Trial Master File according to ICH-GCP, and company SOPs Ensures all documentation is in a state of audit readiness. Prepares study related documents, i.e. clinical trial tools, trackers & templates etc.
• Coordinates with Supply Operations regarding drug forecasting and supply of study drug/comparator drug to sites
• Performs oversight of Central Lab and other ancillary vendors during start-up, conduct, and close-out. Assists with vendor management during the coordination of Investigator Meetings.
• Performs some administrative tasks to support Clinical Operations Department and team members as needed
• Demonstrates knowledge of sample collection, analysis process and sample reconciliation.
• Contributes to and reviews changes in scope and change orders
• Actively participates in the development of department initiatives; contributes ideas when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees