Clinical Trial ManagerAurobindo Pharma Ltd. • East Windsor, California, United States
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Clinical Trial Manager
Aurobindo Pharma Ltd.
- East Windsor, California, United States
- East Windsor, California, United States
Über
Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research-based organization that strives to launch treatments which are accessible to patients that need them.
Acrotech currently markets a portfolio of 5 oncology products including 2 of the leading products in Peripheral T-Cell Lymphoma (PTCL), which is a rare and aggressive blood cancer. We have also launched a novel drug for the treatment of chemotherapy induced neutropenia (CIN).
Job Overview
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.
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
Qualifications - Skills & 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
Education & Experience
* Bachelor's degree in a scientific or healthcare discipline is required; Master's degree preferred
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Sprachkenntnisse
- English
Hinweis für Nutzer
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