Senior Clinical Trial Manager

Astria Therapeutics, Inc.; Boston (MA); Hybrid; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Trial Manager to oversee clinical studies across various phases. This role involves facilitating patient trials, ensuring compliance with GCP guidelines, and managing study activities from initiation to completion. You'll collaborate with cross-functional teams and external partners to ensure timely and effective study execution. This position offers a dynamic work environment where your leadership and expertise will significantly impact the development of life-changing therapies for patients with allergic and immunological diseases. Join a diverse team committed to making a difference in healthcare.

Qualifications

• 5+ years of clinical research experience with 3+ years managing clinical trials.
• Knowledge of GCP/ICH Guidelines for clinical studies.

Responsibilities

• Lead and support clinical study activities in partnership with study teams and CROs.
• Manage all aspects of study progress from start-up to close-out activities.

Skills

Clinical Research

Project Management

Analytical Skills

Problem-Solving

Communication Skills

Education

Bachelor's degree in life sciences

Higher degree in health sciences, nursing, or pharmacy

Tools

Microsoft Office

Clinical systems

Job description

Position Overview:

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria's pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.

The Senior Clinical Trial Manager is responsible for the management of clinical studies across phases including actively participating in a variety of activities to support and facilitate the efficient conduct of patient trials in our clinical research programs. Reporting to the VP, Head of Clinical Operations, you will be responsible for supporting the critical day-to-day clinical study activities, including development of study start-up materials, clinical supplies, case report forms, contracts and budgets, investigator meetings, and regulatory document filings.

Responsibilities:

1. In partnership with Clinical Trial Associate, study teams, and Clinical Research Organizations (CROs), lead and support clinical study activities as defined by the clinical trial operating model.
2. Managing all aspects of study progress from start-up to close-out activities, assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs.
3. Provide expert operational oversight and guidance to support prioritization of activities, review and monitor the work performed, metric compliance, and development of contingency plans, among others.
4. Coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, database set-up, regulatory document filing.
5. Preparing and/or reviewing study-related documents (e.g., Study Operations Plan, Monitoring Plan, Laboratory Manual, CRF Completion Guidelines, and other study-specific documents or manuals). Preparing/reviewing site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
6. Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
7. Communicating with study sites, proactively recognizing problem situations and informing team members to enable issue resolution.

Qualifications:

1. Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field.
2. 5 or more years clinical research experience in industry settings with at least 3 years managing clinical trials.
3. Experience working on phase III, later stage large global studies with multiple vendors, managing submission timelines and associated processes.
4. Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required.
5. Solid project and vendor management, analytical and problem-solving skills.
6. Knowledge of GCP/ICH Guidelines for clinical studies.
7. Ability to work independently and take initiative in a fast-paced work environment.
8. Excellent verbal and written communication skills.
9. Competent computer skills including Microsoft Office.
10. Familiarity with clinical systems.

Astria's Commitment:

At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.

People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.

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