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Sr Clinical Trial Manager

Location: San Jose, CA

Temperature Management

Overview

General Summary:


The Sr. Clinical Trials Manager (CTM) position requires strong leadership, communication (written and oral) and clinical research skills with a high-level working knowledge and experience with regulated clinical research and product development cycle. The PM will provide leadership, oversight, and remain a significant contributor to the overall global clinical development strategy.

 

Must be able to travel 30% of the time including internationally.

Responsibilities

Essential Functions:

  • Must be able to travel a total of 30%, which includes 10-20% International travel.
  • Provide leadership, oversight, and remain a significant contributor to the overall global clinical development strategy for STEMI and Stroke therapies with one or more indications.
  • Ensure development of accurate study budgets, contract development and execution, payments and tracking of study expenditure.
  • Provide oversight and strategic direction for clinical projects.
  • Develop positive relationships with internal and external stakeholders, including key opinion leaders.
  • Work cross-functionally in clinical and pre-clinical research to ensure alignment and communication of the global clinical development strategy for the company.
  • Effective coordination of clinical program to assure progress and timely completion of program goals.
  • Anticipate potential problems within clinical programs and create contingency plans accordingly.
  • Provide contributions to and review of clinical study design and protocol development, including participation in discussions with FDA and other relevant regulatory agencies as needed.
  • Prepare and review for clinical trial reports, publication, and other relevant documents within a program.
  • Contribute to financial, resource, and project management planning needs for various clinical programs.
  • Ensure timely collection of source documentation for all serious adverse events (SAEs) and device related events reported during the conduct of clinical trials and registries.
  • Conduct training and ongoing technical support for completion of eCRFs and related data entry issues.
  • Support clinical product management and accountability as well as clinical site payments based on eCRF compliance.

 

Qualifications

Skill Requirements:

  • Knowledge of the FDA IDE/PMA regulations, GCP, ICH Guidelines, 21 CFR and ISO 14155.
  • Highly proficient with MS Office (Word, Excel, MS Project, Outlook, Visio and PowerPoint).
  • Knowledge of Electronic Data Capturing Systems, CTMS & eTMF Systems
  • Strong cardiovascular background.
  • Experience providing clinical training or support.
  • Demonstrated business acumen to work with physicians and understand competitive intelligence.
  • Demonstrated success with broad cross-functional interactions with internal and external US and international partners and collaborators.
  • Working knowledge and experience in program management.
  • Demonstrated scientific aptitude for medical therapies and medical literature.
  • Demonstrated ability in successful interactions with key global cross-functional teams and individuals.
  • Excellent problem solving and decision making skills.

 

Education/Training/Experience Requirements:

  • BS/BA Degree in Life Sciences, Medicine, Nursing or other technical discipline or equivalent experience. Degree in medical or scientific field desired.
  • 8-12 years of clinical research experience in Class III medical device industry with several years of experience managing EDC, CTMS and eTMF systems.
  • Working knowledge of clinical statistical analysis.
  • Experience and knowledge of the use of investigational devices in clinical studies, in accordance with applicable FDA regulations, Good Clinical Practices, Good Clinical Data Management Practice, and International Standards.

 

Certificates and Licenses:

 

The Certified Clinical Research Associate (CCRA) credential certification is preferred.

 

 

Equal Opportunity Employer – Disability and Veteran

 

 

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