Clinical Trials Program Manager, Medical Devices Operational Compliance Center (Md-Occ)

Amazon Devices and Services is an innovative research and development company that designs and engineers high-profile consumer electronics. We are known for creating the Kindle family of products, and groundbreaking devices like Fire tablets, Fire TV, Halo, and Echo Frames. Working as part of the Medical Devices Operational Compliance Team, the Clinical Trials Program Manager will be working to build a best in class products.
The ideal candidate will have experience building a clinical trial operational strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of Clinical Trials. They must enjoy problem solving and possess practical hands-on knowledge of FDA and IRB submissions and reporting requirements for Clinical Trials across the product lifecycle for Medical Devices.
Key job responsibilities
- Participates in Clinical Trials principal investigator recruitment process.
- Performs site evaluation visits of potential investigators as well as study sites as re. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Coordinates activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring and evaluation of Clinical Trials. Works with this site staff and study sponsor to obtain (IRB/ IEC) regulatory approval for study specific documents.
- Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion on CFR/eCRF, monitoring activities and study close-out activities.
- Assists in resolving any issues to ensure compliance with site file audits in conjunction with the investigator and the study sponsor.
- Assures adherence to the Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
- Performs validation of the source documentation as required by the sponsor. Prepares monitoring reports per the timelines defined in the study protocol by using Amazon templates/ reports.
- Documents accountability, stability and storage conditions of clinical trial materials as required by the sponsor.
- Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction if required.
- Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data (2) on- site source verification (3) Works with sites to resolve data queries.
- May review protocols, eCRFs, study manuals and other related documents.
- Serves as the primary contact with the investigator and the study site, coordinates all correspondences, ensures timely transmission of clinical data with the study site.
- Performs study close-out visits per the study study specific clinical monitoring plan including final investigational product reconciliation.
- Responsible for maintaining procedures pertaining to Part 11 compliance.
- Assists with, and attends investigator meetings for assigned studies.
- Authorized to request site audits due to data integrity concerns.
- Ensures internal and study related training is completed.
- Contribute to development of annual operational budget for clinical research.
- Performs other duties as requested.
- Able to travel domestically and internationally as needed.
A day in the life
As a Clinical Affairs Program Manager, you will work with a unique team supporting ground-breaking new products and collaborating with interdisciplinary teams. At the cutting edge of both academic and applied research, you have the opportunity to join an exciting new team working to design, build, manufacture and launch new, best in class products, together with extraordinarily talented engineers and product leaders.
About the team
The Quality & Lean, Medical Devices Operational Compliance Center (MD-OCC), consists of business process analysts, quality system experts, Program Managers, supply chain experts, regulatory experts, clinical affairs, and internal auditors. Our mission is to establish and manage Amazon Devices and Services Medical Product Quality and Regulatory Systems; enabling the manufacture and distribution of safe, effective and high-quality medical products for at home, mobile health and wellness customers.
We are open to hiring candidates to work out of one of the following locations:
Sunnyvale, CA, USA
BASIC QUALIFICATIONS
- 7+ years of working directly with engineering teams experience
- 5+ years of technical product or program management experience
- Experience managing programs across cross functional teams, building processes and coordinating release schedules
- 6+ years of experience with medical device industry
- BS/BA/BSc or equivalent degree in life sciences, health care and minimum of 4 years of experience with site monitoring/ management for clinical studies. Masters degree preferred
- Current knowledge of medical device Clinical Trials design, clinical research and best practices
- Excellent knowledge of FDA and OUS regulations, GCP, ICH guidelines applicable to the conduct of clinical research
- Experience in monitoring and/or coordinating Clinical Trials is required
- Prior CRO experience preferred
- High Level Proficiency in clinical trial monitoring tools as well as MS Excel, Word and Powerpoint
PREFERRED QUALIFICATIONS
- Post-graduate degree in a scientific discipline or related field
- Experience in human research background with clear understanding of study lifecycle
- Experience running virtual and/or remote Studies
- Familiar with advanced concepts of clinical research
- Excellent written and verbal communication skills to interact with study personnel, sponsor as well as investigator at the study site
- Demonstrates highest ethical standards, actively promotes trust, respect, integrity in all dealings both inside and outside the company
Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.
Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $119,000/year in our lowest geographic market up to $231,400/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. Applicants should apply via our internal or external career site.