Senior Clinical Research Manager

2 months ago

Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full time
Job Overview

Why Choose Cardurion Pharmaceuticals, Inc?

At Cardurion, we are dedicated to enhancing the understanding of the cellular mechanisms that govern heart functionality and are pioneering innovative therapies to combat cardiovascular diseases. Our initiatives aim to modulate signaling pathways that influence heart cell performance, reversing the pathological processes that contribute to cardiovascular conditions. We encourage you to explore our organization to discover how we are leveraging cardiovascular signaling pathways science to enhance health and transform lives globally.

Position Summary:

We are in search of a driven, results-oriented professional to become a part of Cardurion's Clinical Operations team as a Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM). The CTM/Sr. CTM will play a pivotal role in the successful execution of one or more clinical trials, collaborating with functional experts and Contract Research Organizations (CROs) to achieve optimal operational results. This position entails overseeing the daily operations of clinical studies, including initiation, execution, and closure, in compliance with the study protocol, standard operating procedures (SOPs), good clinical practices (GCP), and other relevant regulatory standards. This role typically involves coordination with one or more CROs. The CTM/Sr. CTM is expected to demonstrate strong teamwork, a positive demeanor, and a commitment to delivering essential medications to patients in need.

Key Responsibilities:

  • Lead the multidisciplinary study execution team and collaborate with other departments as necessary for the implementation and execution of the studies.
  • Act as the primary Clinical Operations liaison for cross-functional team members and CROs, as needed.
  • Develop efficient and effective strategies for clinical trial execution; oversee planning and implementation of clinical studies, including budget and timeline management, as well as vendor oversight.
  • Prepare and/or review and approve study-related documents, including but not limited to protocols, informed consent forms (ICFs), study plans, manuals, clinical study reports (CSRs), and NDA submission documentation, as appropriate.
  • Compile metrics and updates for leadership as necessary.
  • Proactively identify, negotiate, and engage the study team in resolving and mitigating clinical study risks, issues, and challenges, escalating to leadership when necessary.
  • Participate in the CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities.
  • Manage interactions with CROs and Clinical Service Providers (CSPs), including sponsor oversight of operational activities (e.g., study management, monitoring, site management, Trial Master File).
  • May serve as a line manager to one or more Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs).
  • Contribute to the development, review, and implementation of departmental SOPs and processes, including the creation and/or review of templates, tools, and training materials.
  • Organize, lead, and manage internal team meetings, investigator meetings, and other study-specific meetings as appropriate.

What We Offer:

  • Highly competitive compensation package with comprehensive healthcare coverage, including medical, dental, and vision.
  • Fully funded Healthcare Savings Account for high-deductible PPO Plan.
  • Four weeks of paid time off annually.
  • Ten company-paid holidays and year-end shutdown.
  • 401k (traditional and Roth options available) with company matching.
  • A suite of Cardurion-paid insurance coverage, including life insurance, short-term, and long-term disability.
  • Flexible spending accounts for medical and dependent care expenses.
Our Mission:To translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Qualifications:

  • Bachelor's degree in a relevant scientific or health-related field.
  • A minimum of five years of relevant work experience in the pharmaceutical or biotechnology sector, with at least three years in a study management capacity.
  • Familiarity with FDA and/or EMA regulations, ICH guidelines, and GCP governing clinical study conduct.
  • Experience managing CROs and external vendors.
  • Proficient in MS Office (Outlook, MS Word, Excel, PowerPoint); knowledge of MS Project is a plus.
  • Some travel may be required for this position, including internal meetings, conferences, or training events.

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