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Sr. Clinical Trial Associate
About Apogee Therapeutics
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, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
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 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
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
- 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
The anticipated salary range for candidates for this role will be $120,000-$135,000/ 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.
What We Offer
- 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
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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