Senior Clinical Trial Associate
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care.
We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”.
If this sounds like you, keep reading!
Role Summary
We are seeking a Sr. Clinical Trial Associate (Sr. CTA) role, who will support 1-3 project teams. In this role you will manage multiple administrative aspects of clinical trials across all project stages, including study start-up, enrollment, study conduct and close-out. This may include creation of study documents, implementing and maintaining trackers, coordinating vendor payments and supplies to research units, performing quality control of clinical trial documents and assisting with study start-up contracting and study coordination activities. This role will also have accountability for managing the collection, review, completeness, and quality of their assigned eTMFs.
Key Responsibilities
- Act as a central contact for the cross-functional study team for designated project communications, correspondence, and associated documentation
- 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 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.
- 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
- Responsible for managing team training assignments and oversight/ownership of due dates to support compliance
Ideal Candidate
- 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
- Extensive experience with 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, SmartSheet, 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
- Position requires up to 15-20%travel, including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year. Travel is also required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office. This position may also require US and international travel to clinical sites and/or medical conferences.
The anticipated salary range for candidates for this role will be $130,000 - $145,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
- 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
- We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
- 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
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