Sr. Clinical Trial Manager

Company: Integrated Resources, Inc.
Location: Cambridge
Posted on: June 23, 2022

Job Description:

Job Description
Title: Sr. Clinical Trial Manager Duration: 6 months +
Location- Cambridge, MA

Sr. Clinical Trial Manager - Hemoglobinopathies (Contract)
Join client's enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach in transfusion-dependent thalassemia (TDT). Reporting to an Associate Director, you will be responsible for managing two global TDT clinical studies. Responsibilities include study planning and execution, timelines, budget, and vendor management. In this position you will be a key team member who will effectively lead the implementation, management and close-out of the two TDT clinical trials to support Regulatory filings and publications.
You will also be responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. Utilize your experience with working independently, influencing, and leading a cross functional internal and external team. You will ensure trial(s) are managed to the highest quality to ensure safety and effectiveness of client's products.
About the role: Responsible and accountable for two concurrent global, (Phase III and Phase IV), clinical studies that adhere to ICH/GCP standards
Oversight of vendors including CROs, Central Labs and independent contractors; actively participates in development of study documents and plans
Ensure data entry/cleaning milestones (including data snapshots) are met
Coordinate patient treatment planning and drive traceability procedures for investigational products
Accountable for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings
Leads/owns formal risk assessment activities; review and approve corrective action plans across study, participate in internal/external study related audits
May perform research site activities, such as on-site or remote monitoring, co-monitoring, training, and motivational visits, as needed
Review of study specific data review, including tables, listings and figures
Communicates study progress, risk and issues effectively throughout the internal organization and with outsourced partners
Manage trial budget
Other Responsibilities: Participate in departmental initiatives such as the development and review of SOPs, Work Instructions and Administrative References
About you: BS/BA/RN Degree in a life science or a health-related field is preferred, with a minimum of 5 years relevant industry clinical development experience and at least 3 years of managing multi-disciplinary project teams
Biopharmaceutical/Biotech experience strongly preferred
Experience and understanding of global clinical trial operations; preference in the rare disease space
Excellent knowledge of GCP, ICH and FDA regulations; working knowledge of international regulations in the EU preferred
Experience with eTMF and Quality Management Systems - Veeva experience preferred
Familiarity with clinical data review and data management processes, including Data Monitoring Committees
Prior experience supporting regulatory filings and inspections and audits desirable
Demonstrates a drive for solutions, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressure
Ability to foster relationships with vendors, clinical sites and cross-functional colleagues based on trust and collaboration
Excellent and transparent communication skills and ability to influence across multiple functions
The ability to independently lead several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving
Thrives in a fast-paced and evolving environment
Must be able to travel up to 25%, domestically and internationally

Keywords: Integrated Resources, Inc., Cambridge , Sr. Clinical Trial Manager, Executive , Cambridge, Massachusetts