Job Title: Senior Clinical Trial Manager
Reports To: Director, Clinical Operations
Functional Area: Clinical Operations
Position Location: Remote (Possible Hybrid)
Exempt/Non-Exempt: Exempt
About Tourmaline Bio, Inc.
We are a nimble, driven and accomplished team of entrepreneurs, physicians, and industry experts with a mission to thoughtfully develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our core values help drive this mission and are the foundation of our company culture: we have a passion for our mission; we believe respect and inclusion are core to the success of our team; we overcome obstacles to deliver results for patients; and we push the envelope.
Our lead program has completed multiple Phase 1 and Phase 2 clinical trials. We launched our Phase 2b clinical trial in Thyroid Eye Disease (TED) in 2023 and our Phase 2 clinical trial in cardiovascular disease in Q2 2024. We plan to initiate our Phase 3 clinical trial in TED later in 2024. More information about Tourmaline can be found at www.tourmalinebio.com.
General Responsibilities:
The Senior Clinical Trial Manager (Senior CTM), with support from Clinical Operations leadership, is responsible for all operational aspects of a clinical study from setup through final report. Depending on the size of the study, the Senior CTM may coordinate the activities of several other in-house clinical team members (e.g., Clinical Research Associates, Data Managers, Supply Chain, etc.), as well as several external clinical vendors and/ or consultants. The Senior CTM may also assume the role of the in-house Lead Clinical Research Associate for a study, as needed.
Responsibilities:
- Implement clinical project plans in accordance with key study documents (e.g., protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
- Drive all aspects of study start-up, including CRO selection
- Develop and manage clinical trial budget and facilitate contract review
- Serve as the primary point of contact for sites, vendors, and CROs
- Monitor CRO and vendor adherence to scope of work
- Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with key study documents and all regulatory requirements
- Proactively identify, resolve, and escalate issues that jeopardize timely clinical study completion
- Participate in vendor, site and CRO audits as appropriate
- Participate in site monitoring visits as necessary
- Plan and present at investigator meetings, company, and other meetings as necessary
- Develop internal tracking and reporting tools for reporting study status to Leadership and facilitate internal project team meetings
- Adhere to relevant company policies and SOPs, cGCP/ICH guidelines, QC/QA procedures, as well as relevant clinical regulatory requirements
Education:
- Bachelor’s degree in a scientific discipline is required
- Advanced degree or certification is a plus
Experience and Attributes:
- 5+ years of clinical trial operations experience in a biotech, pharmaceutical, CRO, clinical research site or related healthcare company
- Experience working on a multi-phase clinical program is a plus
- Robust understanding of the drug development process is a plus
- Highly organized, outcome-oriented, self-motivated performance
- Ability to thrive in a fast-paced and evolving environment
- High level of integrity, ethics, and discretion
- Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
- Strong working knowledge of cGCP/ ICH guidelines, and US and international clinical regulatory requirements
- Strong written and oral communication skills
- Periodic travel to Tourmaline office in New York is required
- Ability and willingness to travel to domestically and internationally (10-20%)
Base Salary Range:
Base Salary Range: $138,000 – $165,000, based on candidate professional experience level.
Note:
This job description is written as a guideline to inform a current or prospective Tourmaline employee of what is or will be generally expected in a given position. The description is not intended to be all-encompassing or limiting in any manner. Duties and responsibilities other than those listed above may be included as needed.
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Tourmaline Bio, Inc. is proud to be an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other protected characteristics under applicable law.
