Apogee Therapeutics is hiring a
Clinical Trial Associate

Summary

Join Apogee Therapeutics as a Sr. Clinical Trial Associate (Sr. CTA) to support 1-3 project teams in managing multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out.

Requirements

• BS/BA in Life Sciences or equivalent
• 4+ years of experience in similar position in Biotech, Pharmaceutical or CRO industry and in R&D environment
• Biotech and/or pharmaceutical company (sponsor) experience
• Extensive experience managing electronic TMF, including set-up, maintenance, QC/ QR and query management. Familiar with DIA reference model
• Knowledge of ICH/GCP and applicable regulations
• Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global)
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox
• Strong critical thinking, organizational and time-management skills
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability and willingness to travel up to 10% including a minimum of 4 times per year for All Hands meetings

Responsibilities

• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
• Set up, maintain and perform QC reviews on study specific electronic Trial Master Files to ensure inspection readiness and compliance with applicable regulations and Good Clinical Practices
• Track and report TMF health metrics and ensure documents are processed and correctly filed
• Track and report study metrics; inclusive of start-up, data management, and contracting as needed
• Participate in GxP audits and related clinical compliance activities
• Prepare and track study documents (e.g., contracts, budgets, IRB documentation)
• Maintain databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, and clinical data or sample flow, etc.) and assist in ensuring all systems, including but not limited to, EDC (Data Management), eTMF, CTMS, Payments, etc. are best utilized per Quality standards
• Administer user access and change control within Apogee’s electronic systems
• Assist in User Acceptance Testing for all EDC needs in regard to Data Management and all Clinical Systems
• Assist with vendor management and associated logistics, as assigned
• Contribute to the creation of presentations, as needed for project, departmental, sponsor and/or business development presentations
• Collaborate with Clinical Project Manager, Clinical Supply Unit and QA in order to manage activities related to Clinical Supplies. Manage study related payment procedures. Interact with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel). May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training
• Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual. Participate in the completion and review of the RFPs in collaboration with the Clinical Project Manager
• Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
• Assist in creating and implementing departmental procedures Assist with information gathering, literature searches, and creation of presentations, as needed

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