Job Type
Full-time
Description
Why join Cardurion Pharma?
At Cardurion, we are advancing the understanding of the cellular mechanisms that regulate heart function and are developing new treatments to address cardiovascular disease. Our programs seek to modulate signaling pathways that regulate heart cell function to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our site to learn more about our Company and how we are advancing the promise of cardiovascular signaling pathways science to improve health and impact lives around the world.
The Role
We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Clinical Trial Manager (CTM) / Sr. Clinical Trial Manager (Sr. CTM). The CTM/Sr. CTM will be responsible for successfully executing on one or multiple clinical trials in collaboration with functional subject matter experts and CRO(s) to deliver successful operational outcomes. The CTM/Sr. CTM is accountable for the day-to-day operational oversight of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. This activity typically is coordinated in conjunction with one or more Contract Research Organizations (CROs). The CTM/Sr. CTM exhibits strong teamwork, a positive attitude, and values bringing important medicines to patients in need.
Here’s What You’ll Do
- Leads the multidisciplinary study execution team and collaborates with other functions as required for implementation and execution of the study(s).
- Serves as the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate.
- Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management.
- Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and manuals, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
- Prepares metrics and updates for Leadership, as appropriate.
- Proactively identifies, negotiates, and successfully engages the study team in the resolution and/or mitigation of clinical study risks, issues, and challenges and escalates to leadership when appropriate.
- Participates in CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities.
- Manages CRO/Clinical Service Providers (CSPs) interactions, 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).
- Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials.
- Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate.
Here’s What We’ll Bring To The Table
- Highly competitive package with healthcare coverage including medical, dental and vision.
- Fully funded Healthcare Savings Account for high-deductible PPO Plan.
- 4 weeks paid time off annually.
- 10 company paid holidays and year-end shut down.
- 401k (traditional and Roth offered) with company match.
- 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: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.
Requirements
Here’s What You’ll Bring to the Table:
Core Competencies
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Possesses a broad view of the departmental goals and sees the “big picture” scientifically and strategically.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction.
- Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines.
- Must have excellent interpersonal, written and verbal communication skills.
- Skilled in developing collaborative internal and external relationships.
- Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
Qualifications
- BS or BA in a relevant scientific or health related field.
- A minimum of 5 years of related work experience in the pharmaceutical or biotechnology industry, with at least 3 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 a plus.
- Some travel may be expected for this position including internal meetings, conferences or training events.
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