Senior Clinical Trial Manager, Clinical Operations

Full Time On-Site/Hybrid Data Management CTM Clinical Operations Apply for this Job Remix launched with a vision to transform patient’s lives through modulation of RNA processing. Our breakthrough science provides a path to identify small molecules that impact the expression of disease driving mRNAs and proteins. We take on the challenge of addressing drug targets in diseases of high unmet medical need to bring new therapeutic options to patients. Remix has a commitment to demonstrate the highest levels of scientific integrity with urgency because those patients are counting on us to deliver. With an in-house technology platform built from scratch, we have rapidly generated multiple drug discovery programs that are advancing towards the clinic.

Position Summary:

Remix seeks a high-energy and experienced individual with versatile skills specific to operational management and oversight of clinical trials. As Senior Clinical Trial Manager (CTM) you will be responsible for the planning, management, budgeting, oversight, and overall execution of assigned clinical studies. This role will work closely with Clinical Development Leadership and across internal functions to provide input on key processes and infrastructure to ensure proper study oversight in a fully outsourced model for the first of many Remix Clinical Programs. The ideal candidate has played a critical role in managing global clinical trials with a solid understanding of good clinical practice and applicable regulatory requirements. You will be responsible for managing CROs and external vendors to execute global clinical studies which require concert amongst numerous sourcing partners and integration of complex data sets to support regulatory submissions and applications.

Principle Duties and Responsibilities:

• Manages clinical and specialty CROs, Laboratories, and Clinical Trial Sites to successfully deliver high visibility, high impact clinical trials.
• Delivers crisp execution from planning to close-out to ensure adherence to timelines and goals while maintaining quality in accordance with FDA, EMEA, GCP, and ICH guidelines to deliver regulatory-grade data and outputs on time and within budget.
• Participates in authoring and reviewing study-related documents and plans such as Project Plans, Site Management Tools, Informed Consent, etc.
• Provides oversight for sample tracking and management across multiple labs in multiple geographies.
• Works collaboratively with internal and external cross-functional teams.
• Performs QC and oversight of CRO-housed Trial Master Files (TMFs) to ensure adequate and compliant study documentation.

Qualifications:

• Minimum 5-10 years of experience in clinical trial management at a pharmaceutical company, biotech, or CRO.
• Demonstrated experience with developing clinical operations strategy and plans including site monitoring, risk mitigation plans, recruitment plans, and CRO/vendor oversight plans.
• Experience managing complex Phase I through III studies, preferably in oncology and rare diseases.
• Demonstrates extensive knowledge of clinical operations methodologies, organizational, project management, and leadership capabilities as well as strategic insight, strong judgement, and effective problem-solving.
• Extensive knowledge and application of GCP/ICH guidelines and FDA regulations in clinical trials.
• Experience monitoring clinical studies and conducting and/or overseeing PSVs, SIVs, IMVs, and COVs is a plus as is data, sample reconciliation and management.
• Ensures a consistent, standardized approach to operational activities and clinical project management. Champions continuous quality improvement.
• Excellent interpersonal and communications skills (verbal and written), as well as problem solving and organization skills.
• Proven ability to work independently and proactively in a fast-paced environment while also exceling in cross-functional collaboration.
• Familiarity and aptitude on managing external spend is favorable.
• An interest in working alongside passionate, driven and fun teammates at a company rapidly evolving from Research into Development and beyond.
• A passion for making medicines patients need.