Clinical Research Operations Manager
1 week ago
Why Consider Cardurion Pharmaceuticals, Inc?
At Cardurion, we are dedicated to enhancing the understanding of the cellular mechanisms that govern heart function and pioneering innovative therapies to combat cardiovascular diseases. Our initiatives aim to modulate signaling pathways that influence heart cell operations, striving to reverse the pathophysiological processes that contribute to cardiovascular conditions. We encourage you to explore our company and discover how we are advancing the potential of cardiovascular signaling pathways science to enhance health and positively impact lives globally.
Position Summary:
We are in search of a driven, results-oriented professional to become 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 oversee the successful execution of one or multiple clinical trials in partnership with functional subject matter experts and Contract Research Organizations (CROs) to achieve optimal operational results. This role is accountable for the daily operational management of one or more clinical studies, encompassing study initiation, execution, and closure in alignment with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other relevant regulatory standards. This work is typically coordinated alongside one or more CROs. The CTM/Sr. CTM demonstrates strong collaboration, a positive mindset, and a commitment to delivering essential medicines 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 study(s).
- Act as the primary Clinical Operations liaison for cross-functional team members and CROs, as appropriate.
- Develop efficient and effective clinical trial execution strategies; guide the planning and execution of clinical studies, including management of study budgets, timelines, and external vendor relationships.
- Prepare and/or review and approve study-related documents, including but not limited to Protocols, Informed Consent Forms (ICFs), study plans and manuals, CRF Completion Guidelines, Clinical Study Reports (CSR), and NDA submission documentation, as applicable.
- Compile metrics and updates for Leadership, as necessary.
- Proactively identify, negotiate, and engage the study team in resolving and/or 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/Clinical Service Providers (CSPs), including sponsor oversight of operational functional 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 range of Cardurion-paid insurance coverage, including life insurance, short-term and long-term disability.
- Flexible spending accounts for medical and dependent care expenses.
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:
- BS or BA in a relevant scientific or health-related field.
- A minimum of five years of relevant work experience in the pharmaceutical or biotechnology industry, with at least three years in a study management role.
- Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
- Experience in managing CROs and external vendors.
- Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project experience is a plus.
- Some travel may be expected for this position, including internal meetings, conferences, or training events.
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