Senior Clinical Operations Process and Study Training Specialist

March 24

Apply Now

Receive Emails with Similar Jobs

Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Apogee Therapeutics is a clinical stage biotechnology company focused on developing novel biologics for the treatment of inflammatory and immunology disorders. The company targets major markets in inflammatory and immune diseases such as atopic dermatitis, asthma, chronic obstructive pulmonary disease, eosinophilic esophagitis, and other related conditions. Apogee Therapeutics seeks to reshape the current standard of care by advancing antibody therapeutics that target well-established biological mechanisms, with the potential to address dermatological, respiratory, and gastroenterological issues. The company is committed to creating a psychologically safe workplace while prioritizing innovative treatment options for those living with these conditions.

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

📋 Description

• We are seeking an experienced Sr. Clinical Operations Process & Study Training Specialist to support the development and implementation of study-specific training across all programs via the Learning Management System (LMS), ensuring that cross-functional study teams receive comprehensive training on study protocol and procedures. • The ideal candidate will support adherence to GCPs, SOPs, and regulatory agency guidelines while maintaining knowledge of study operational processes to ensure study training compliance. • This role may also be involved in supporting the implementation of best practices and processes in support of operational excellence and inspection readiness. • Additionally, you will engage in regular communication with internal study team members to provide study training updates, support the management of study training effectiveness, address potential study training challenges across therapeutic areas, process all training assignments/requests and troubleshoot routine inquiries in real-time.

🎯 Requirements

• A bachelor's degree and relevant professional experience are required. • A minimum of 5 years of clinical related experience. • Proficiency in LMS with knowledge of utilization features is required. • Ability to develop engaging and effective study training materials, including e-learning modules and presentations. • Knowledge of the principles and practices of SOP management as applied to the pharmaceutical/biotech or contract research organization industry related to study training. • A solid understanding of clinical research with thorough understanding of clinical trial processes, regulatory requirements, and GCP guidelines pertaining to study training requirements. • Attention to detail and commitment to quality. • Excellent interpersonal and decision-making skills. • Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver department objectives. • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with cross functional teams and within assigned timelines. • Experience working in a growing, fast paced organization. • Collaborative team-player. • Excellent written and verbal communication to deliver study training effectively and interact with diverse stakeholders. • Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless. • Position requires up to 20% travel - including 2 All Hands Meetings plus functional meetings.

🏖️ Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless. • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Flexible PTO. • Two, one-week company-wide shutdowns each year. • Commitment to growing you professionally and providing access to resources to further your development. • Apogee offers regular all team, in-person meetings to build relationships and problem solve.