Skip Navigation

Remote Senior Clinical Trials Manager or Associate Director
Boston, MA

Back To Job Board

Temp To Permanent

$1 - $2


 

Sr. Manager / Associate Director Clinical Development Operations

 Remote but preference is East Coast

Report to:
Sr. Vice President, Clinical Development Operations (CDO)

 About Company 

Company (“RTX”) is a clinical-phase company.  Our core technology combines proprietary dry-powder inhaler device technologies and advanced particle engineering-based inhaled drug formulation approaches to develop novel therapeutics that deliver the drug more directly to the lung and lung periphery, instead of in the oropharyngeal cavity. 

Position Description

  • Manage end-to-end clinical contracts between external service providers (ESP) and internally at “RTX”
    • Responsible for invoice review and adjudication with ESP
    • Lead role in annual budget projections for current and new ESP
    • Identify new ESPs as necessary
  • Working with clinical development team colleagues, create and maintain internal clinical trial timelines and study-specific work plans using internal templates
    • Prospectively identify gaps and constraints and prosecute findings with clinical development team
  • Responsible for set up with ESP and logistics on all clinical trial shipments to and from research sites
  • Subject matter expert (SME) on device malfunction tracking, reporting, and remediation re-education at site and ESP levels
    • Provide and deliver remediation training within context of internal standards and review
  • Work with clinical development and clinical operations teams to create SME training as needed for clinical study conduct
    • SME for “RTX” electronic training portal
  • Sole management of GCP training matrix for Clinical Department
    • Work with QA to identify training gaps and procure method for gap training
    • Responsible for organizing and providing annual company wide GCP training in collaboration with Heads of QA and CDO
  • Sole “RTX” manager and curator of biological samples from clinical trials with approved external reference labs
    • Responsible for liaising with external parties ensuring on-time analysis and data transfers
  • Core NDA preparation team member
    • Key planning role
    • Provide information for sections
    • Coordinate timing and quality of deliverables from ESPs

 

Candidate Profile

  • Internally motivated to deliver high-quality work products on time and within budget
  • Excellent communication and planning skills
  • Ability to recognize personal information gaps and seek advice and counsel of internal associates and engage in appropriate self-study
  • Thrives on learning new aspects of clinical development work and integrating these with current expertise
  • Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs
  • Working knowledge of ICH GCP
  • Minimum of 7 years working in clinical development and/or clinical operations roles at a biopharma or clinical contract research organization with a minimum of 4 years in a management capacity
  • Advanced working knowledge of Microsoft Excel, PowerPoint, and Project
  • Bonus: working experience using Smart Sheets®, One-Pager Pro™, Medrio and Oracle clinical databases

Remote Senior Clinical Trial Manager

SENIOR CLINICAL TRIAL MANAGER- located in NorthEast is preference

Eastablished, US clinical-stage biopharmaceutical company (publicly traded) focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. 

 

About the Role:

The Sr. Clinical Trial Manager will be responsible for independently managing multiple clinical trials of moderate to high complexity. The Sr. CTM will assume many critical activities including the management of internal and external stakeholders, ownership of the clinical trial strategy for execution, serving as a key participant in regulatory discussions and leading a high performing study team towards shared objectives.  

Key tasks and responsibilities: 

Manages all clinical aspects of study including:  

  • Responsible for selection, qualification, and management of vendors to support clinical trial execution
  • Develops and manages comprehensive study timelines and metrics and ensures completion of study deliverables 
  • Proactively identifies and resolves clinical project issues 
  • Provides study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel; 
  • Plans, executes, and leads study-specific meetings (e.g., internal core team meetings, investigator meetings, Advisory Committee)
  • Participates in site monitoring visits as appropriate 
  • Provides input for the design of the Informed Consent Form(s), CRFs, monitoring conventions, edit checks, etc 
  • Reviews monitoring reports to ensure quality and resolution of site-related issues 
  • Ensures tracking and review of protocol deviations and assesses impact on study data 
  • Uses operational and therapeutic expertise to optimize trial design and execution. 
  • Typically works with the Director to design clinical trial protocols consistent with the clinical development plan and develop an ongoing data review plan to ensure appropriate patient recruitment
  • Develops relationships with investigators and site staff; critical to be comfortable engaging KOLs in scientific discussion
  • Participates as Core Team Member and assists the Director, Clinical Operations with management of Program level activities.

  

About You:

  • BS/BA in life sciences preferred MUST HAVE GLOBAL TRIAL EXPERIENCE (please specify countries)
  • A minimum of 7 years of direct experience in clinical trial execution 
  • Experience managing clinical trials in Asia, Middle East and Africa highly preferred
  • Experience managing clinical trials both fully outsourced as well as managed directly
  • Excellent communication (verbal and written), organizational and problem solving skills
  • Prior experience developing and managing clinical trial budgets
  • Demonstrated experience with Oncology, Hematology, and/or rare disease studies preferred
  • Experience managing external contract research relationships. 

 FULLY REMOTE- one year of a contract (full benefits included)- and then position can go perm



Back To Job Board

Submit Your Resume

"*" indicates required fields

First Name*
Last Name*
Max. file size: 20 MB.
Drop your resume and other files here or upload here
This field is for validation purposes and should be left unchanged.