Senior Clinical Trial Manager

Company:

Eidos Therapeutics

Role Title:

Senior Clinical Trial Manager

Department:

Clinical

Company:

Eidos Therapeutics is developing a novel treatment for transthyretin (TTR) amyloidosis (ATTR), a progressive, fatal disease affecting multiple organs including the heart and peripheral nerves. Current treatment options focus on managing the symptoms of the conditions, but do not address the underlying cause of the disease: TTR tetramers destabilized by mutations or age. Eidos’ lead compound, AG10, is a small molecule that binds and stabilizes TTR in the blood, preventing the formation of amyloid and potentially halting progression of the disease. Launched in 2016 after years of research supported by Stanford’s TRAM and SPARK programs, Eidos is led by a team of veteran biotechnology executives. Together with patients and physicians, the company aims to provide a safe, effective treatment for ATTR as quickly as possible.

Position Summary:

The Senior Clinical Trial Manager (Sr. CTM) is responsible for managing operational activities of assigned clinical programs. This individual role provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials at Eidos Therapeutics. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO training, vendor management and review of agreements related to CRO clinical activities. Partner with key stakeholders – internal and external – to ensure continuous harmonized operations of clinical operations activities and to maintain high standards for functioning in a cross-functional environment. 

Essential Skills & Functions:

  • Responsible for representing Clinical Operations (ClinOps) on cross-functional study teams and Vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
  • Manages cross-functional study teams and vendor operational meetings to ensure project goals and timelines are met
  • Provides leadership for ClinOps related issues and advise management team of potential issues and solutions 
  • Manages, coaches and develops junior staff, as applicable, in order to maximize their capability and contribution to provide high quality deliverables
  • Responsible for the review and oversight of tasks in study data management plans for operations and all operational activities associated with clinical trials
  • Responsible for ensuring that all  components of the trial master file
  • (TMF/eTMF) are up to date and accurate for Eidos assigned investigational trials
  • Monitors global regulatory intelligence for global industry practices for operational efficiency and compliance
  • Responsible for operational guidance for investigators and provide CRO training related to  the study conduct
  • Responsible for managing queries for clinical studies from CROs and address issues raised by CROs or other service providers
  • Participates in the conduct of audits and support regulatory inspections related to GCP
  • Addresses consistency in collection, processing and evaluation of clinical data
  • Contributes to the development of ClinOps SOPs and company policies to ensure compliance with regional regulatory requirements and drive continuous improvements 
  • Represents Clinical Operations on cross-functional teams 
  • Supports Eidos sponsored clinical trials and development programs

Preferred Education and Experience:

  • BA required in a scientific/medical field.  Advanced degree preferred.
  • Minimum 8 years of experience in Clinical Operations, working with CROs and other vendors 
  • At least 5 years of management experience in a clinical research environment
  • Previous experience working in cross-functional environment 
  • History of successfully developing effective relationships with outside vendors and CROs
  • Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations 
  • Demonstrated skills in negotiation, multi-tasking, organization and decision making
  • Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
  • Ability to travel to regional and global sites 
  • Prior experience working in a start-up environment is a plus

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