[Hiring] Sr. Clinical Operations Process & Study Training Specialist @Apogee Therapeutics
Mar 22, 2025 - Apogee Therapeutics is hiring a remote Sr. Clinical Operations Process & Study Training Specialist. 💸 Salary: $110,000 - $135,000 per year. 📍Location: USA.
Role 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.
Key Responsibilities
- Support and upload course materials within the LMS platform, including e-learning modules, videos, quizzes, and assessments, tailored to specific clinical trial protocols and study procedures.
- Assign and link study training documents through the LMS.
- Administer the LMS, including user access control, assigning courses to appropriate staff, tracking course completion, and generating reports on training progress and compliance.
- Support in the development and maintenance of a cross-functional role-based study training matrix.
- Support the delivery of instructor-led training sessions, both in-person and virtually, for clinical study teams.
- Support with ensuring all training materials and delivery methods adhere to relevant regulatory guidelines (e.g., GCP, ICH) and company standards.
- Monitor learner performance through assessments and identify areas for improvement, providing targeted training interventions (i.e. lessons learned, CAPAs, workshop and email blast) when necessary.
- Provide support in SOP development and supporting documentation.
- Work closely with clinical operations teams and/or cross-functional teams to align training needs with study requirements.
- Support in inspection readiness exercises with the team related to study training and any reconciliation or gap processes.
- Ensure effective preparations for regulatory inspections related to study training.
- Support strategic initiatives in preparation for agency inspection readiness.
Qualifications
- 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.
Requirements
- 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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
|
Salary
💸
$110,000 - $135,000 per year
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 22, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
